title: document no: csvp-um-igmp- csvp 3.000.001 manual … · 2019-02-26 · title: csvp –...
TRANSCRIPT
Title:
CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
Page: 1 of 122
1
Approvals
Name Title Organization Signature Date
System Owner:
Richard Soltero
President InstantGMP
6/2/16
Software QA:
Gretchen Rizor
QA InstantGMP
6/1/2016
Version History
Version Date
(MM/DD/YY
YY)
Description of Change
00 02072014 New Document
01/ 2.045 070214 Made changes for the new Unit table/page/workflow.
02/
2.045.008 09/10/14 Updated the new specification workflow.
03/2.045.009 11/17/14 Updated with new batch material use workflow
04/2.050.001 05/18/2015
The default Role can be assigned from the personnel screen.
Personnel may login immediately after role assignment on this
screen. (p 21) Added Optional Features section (p20) Added
note about ability to sort by batch issuance stamp (p89)
Deleted signatures for Material vendor qualification and
updated screen shot. (p 39)
Updated new specification workflow (pp 40-45) Updated
reports to reflect being sourced from within GeneXus. (pp
99-102)
05 /
2.051.002 07/22/2015
Added a section for the new barcode scan features for user
badges and material labels. Added Sign with badge add tests
and browse buttons to icon glossary. Edited Order to sort with
new icon in glossary.
06/
2.052.001 12/2/2015
Deleted CPC, addressed client change, deleted : Selecting “Y”
from the “Qualified Vendor” dropdown will return all
materials that have qualified vendors. “N” will return all
materials whose vendor has not been qualified. “Clear” will
return all materials.”
2.053.002 12/13/2016 project changes, Product name, Primary container, copy
function, version up function, scale up function,
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CSVP – InstantGMP™ User
Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
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2.054.002 05/09/2016 Min max patch – new error messages
3.000.001 05/09/2016 See release notes below
Table of Contents
Table of Contents ............................................................................................................................ 2 Release Notes: ................................................................................................................................. 3 User Manual Summary ................................................................................................................. 11 Overview of Main Menu and Sub-menu choices ......................................................................... 11
Abbreviations ................................................................................................................................ 13 Definition Glossary ....................................................................................................................... 15 Icon Glossary ................................................................................................................................ 18
Manufacturing Process Overview ................................................................................................. 24 Starting a New Project .................................................................................................................. 24
Set-Up ........................................................................................................................................... 25 Adding Personnel ...................................................................................................................... 25
Vendors ..................................................................................................................................... 28 Material Types .......................................................................................................................... 30 Material Status .......................................................................................................................... 32
Storage Condition ..................................................................................................................... 34 Unit ........................................................................................................................................... 34
Facility ...................................................................................................................................... 36 Room ......................................................................................................................................... 36 Bin Location.............................................................................................................................. 37 Equipment ................................................................................................................................. 38 Tests .......................................................................................................................................... 39
Methods..................................................................................................................................... 40 Countries ................................................................................................................................... 41
Material ......................................................................................................................................... 43
Material Specifications ................................................................................................................. 46 Creating a Project .......................................................................................................................... 51
Project Definition ...................................................................................................................... 51 Requisitions................................................................................................................................... 59
Inventory ....................................................................................................................................... 62 This module includes Receipt, Status update and Use of a material. ........................................... 62
Material Receipt ........................................................................................................................ 62
Inventory Status ........................................................................................................................ 65 Inventory Management ............................................................................................................. 68 Inventory Location .................................................................................................................... 71 Depleted Inventory.................................................................................................................... 72
Master Batch Records ................................................................................................................... 77
Master Record Cover Page ....................................................................................................... 80 Master Record: Bill of Materials .............................................................................................. 81
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Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
Effective upon last signature date
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Master Record Equipment ........................................................................................................ 84 Master Records In-Process Tests .............................................................................................. 85 Master Production Record Manufacturing Instructions ............................................................ 86 Master Record: MPR Approvals ............................................................................................... 92
Batch Production Record .............................................................................................................. 94 Batch Production Cover Page ................................................................................................... 95 Batch Record Manufacturing Instructions .............................................................................. 100 Batch Record Approval........................................................................................................... 107
Audit Log .................................................................................................................................... 109
Reports ........................................................................................................................................ 112 Barcode ....................................................................................................................................... 115
_____________________________________________________________________________
Release Notes:
InstantGMP Release Notes for Version 3.000.001 5/9/2016
New User Interface Features in v3.000
• Personalized view on each screen
• Move, resize or hide columns in grids
• Clear Control Preferences Icon clears all view settings on a screen and restores default
view on that screen
• Sort grid data by any column heading
• Collapse and restore menu and search panels
• Set quantity of rows to display for each grid
• Set favorite menu items
• Icons only inside lists; buttons with text everywhere else
• The search and filter functions in a collapsible panel to the right
• Search starts as soon as characters are entered (some delays may be experienced if there
are a lot of records in a grid)
• Page control, "Confirm", "Cancel", "Close" in the bottom panel
• Insert icon replaced by "Add New Record“ button in bottom panel
• Menu in a collapsible panel on the left
• Open folder icon will indicate that the submenus are displayed and a closed folder icon
will indicate that the submenus are hidden.
• Redundant check boxes eliminated
Error messages
• Appear at the top right of the page
• Disappear after a few seconds, but can be recalled by clicking its tab
Title:
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Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
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Favorites
• Right click on menu item adds title to favorites
• Star icon appears in main header when a favorite is selected
• Clicking star icon shows that specific users' favorites only
• Clicking on “Home" icon at the left side of “Favorites“ shows all menu items
Check mark colors have meanings
• Grey check mark means True (selected), transparent means false
• Yellow check mark means an action is expected
• Green check mark means action is completed
• Red check mark means a problem that stops the workflow
Bin Location Features
• Facility and room specific Storage at each facility identified by Bin location
• Materials in each facility are tracked and managed separately from the inventory at the
other facilities
• Bin Location shown on Inventory summary screens
• History of changes in Bin Location maintained in system
• Bin Location report shows the current inventory in a specified Bin
• Inventory Location is accessed from Inventory Management screen
• To assign/change a material’s location
Select Facility
Select Room
Select Bin where material will be stored
Sign and Confirm
Current Inventory Report
• Now shows bin location of each item in inventory
• Filters show what is in a specific bin location
Other New Features in v3.000
Digits and decimals
All numeric fields now show 6 digits to the right of the decimal
When there are more than 3 digits to the left, commas appear
A single click on the number highlights the entire number and allows it to be replaced
Specifications
When a new version after version 1 is initiated a “Reason for Change” field appears.
New BRP Features
BPR Manufacturing Instructions Summary now in grid format
Status column shows colored icon indicating status of manufacturing step
Yellow check mark means an action is expected
Title:
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Manual-3.000.001
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Green check mark means all actions on that step are completed
Red check mark means a deviation occurred and requires a QA signature
InstantGMP Release notes for version 2.054.001 03/01/16
Improvements
• Automatic conversion of Unit on BPR Instructions to Material Unit.
• Automatic conversion of Unit on BPR Instructions Usage (on multiple lines) to Material
Unit.
Fixes
On some instances when Inventory levels were above 100% the application experience a
printout error.
When a material was added to inventory, the default option was REJECTED instead of
QUARANTINE.
Application was not considering the scenario of using different types of Units in the BPR
Instruction material usage and Target Unit.
Access to Client Option on Administrator menu was not visible for Administrators.
In some instances, when the Production Id was bigger than 40 characters the Inventory
usage on that Batch was not properly shown.
InstantGMP Release Notes for Version 2.053.002 1/6/2015
This version is a patch fix needed for allowing distributors not using units to be able to create
new BPRs from existing approved MPRs.
InstantGMP Release notes for version 2.053.001 12/11/15
New Functionalities
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Manual-3.000.001
Document No: CSVP-UM-IGMP-
3.000.001
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• New MPR and BPR workflow allows users to navigate between manufacturing
instruction steps without scrolling on summary page.
• New BPR functionality automatically checks for quantity used of material on each step
for defined range.
• Added option to Unlock “Locked” MPRs and make edits. Signature and comment log
retained for that version.
• Introduced Medical Device Manufacturing Industry nomenclature.
• New Min and Max fields to set at the MPR manufacturing instruction steps calling for
use of material part #s.
• Smart fields for Min and Max on the BPR alert user to OOS addition of material.
• New smart messages alert user to inconsistencies in the BOM and the manufacturing
instruction steps with material part # use.
Improvements
• Signature for material use now included on the inventory traceability table in the BPR.
• Inventory Value report now expresses conversion of values based on Cost entered at the
material requisition screen.
Fixes
Some minor spelling errors within error messages.
Filter options on Material Types were not properly displaying results.
Under certain conditions BPR printout showed twice when printing BPRs
Unit for approved inventory shown on Batch issuance error message updated.
InstantGMP Release 2.052.001 12/6/15
New Functionalities
• Expanded badge signature capabilities to system-wide usage.
• Added new workflows focused on Project Management functionalities allowing for
projects to include multiple products for multiple clients with multiple user access control
under multiple roles.
• Added new Material Classifications to help employ naming conventions for incoming
materials versus outgoing manufactured, packaged or labelled WIPs or finished goods.
• Updated the definition of the Product Name which now includes a Material Name,
Strength, Batch Unit and Primary Container and will be displayed as such.
• Added option to “Reject” MPRs.
• Added MPR status definitions for a clearer status control
• In-Process
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• Locked
• Rejected
• Approved
• Added new functionality and Rules for creating MPRs:
• More rules for better Version control and traceability
• More rules and more copy options for better control and traceability
• Option for Automatic Scale up/down of recipe
• Added ability to hide unused or superseded MPRs
• Added sorting for hidden, visible, or all MPRs
• Added new BPR status definitions for clearer processing control
• Generated
• Issued
• In-Process
• Locked
• Reviewed
• Added to Inventory
• Added automated population of Bill of Materials Quantities to be used in BPR
manufacturing instructions.
• Automated population of material use data from the inventory screens to the BPR
instructions with a list of vendor lots and total quantity of material used.
• Added new Inventory Value Report.
Improvements
• Simplified Menu Navigation based on new workflows.
• Improved MPR and BPR printouts.
• Pared down auto filter drop down for authors to only include roles that can write MPR.
• Increased level of detail on Vendor and Material traceability reports.
• Changed Manufacturing date to transition from BPR’s “Issued” to “In-Process” when a
Manufacturing Instruction is open for the first time.
• Simplified change of roles for user with multiple roles.
• Auto-assignment of PM and QM personnel to projects for better visibility and ease of
use.
Fixes
Access to attachments on Approved MPR’s Manufacturing Instructions
Some “Sort” and “Search” functions on main screens not working as expected.
Under certain conditions, if you changed your password and immediately logged out, you
couldn’t login again unless reopening the browser.
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Manual-3.000.001
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InstantGMP MES Release notes version 2.051.002 6/25/15
New Functionalities
New barcode scanning solution that enhances material handling.
Ability to permanently “hide” and filter Master Records.
New system-wide digital signature scheme implementation through barcode scanning of
validated user badges.
Implementation of Company Logo on login screen along with Company name on
application header for more clarity on customers with multiple instances.
Improvements
Extended Specification Acceptance Limit field to 120 characters long on PDF print out
under Material Specifications
New mechanisms for attachment handling, making them more efficient and user friendly.
Improved company boarding and Material import mechanism.
Lock down of Production # upon QM approval for easier GMP compliance.
New redesign and export functionalities for Quarantine Reports
Improved usability decreasing visibility on non-essential actions.
Fixes
Under certain conditions after session timeout, an immediate login would render the main
menu invisible.
Minor cosmetic fixes on MPR PDF printout.
New Functionalities
New barcode scanning solution that enhances material handling.
Ability to permanently “hide” and filter Master Records.
New system-wide digital signature scheme implementation through barcode scanning of
validated user badges.
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CSVP – InstantGMP™ User
Manual-3.000.001
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Implementation of Company Logo on login screen along with Company name on
application header for more clarity on customers with multiple instances.
Improvements
Extended Specification Acceptance Limit field to 120 characters long on PDF print out
under Material Specifications
New mechanisms for attachment handling, making them more efficient and user friendly.
Improved company boarding and Material import mechanism.
Lock down of Production # upon QM approval for easier GMP compliance.
New redesign and export functionalities for Quarantine Reports
Improved usability decreasing visibility on non-essential actions.
Fixes
Under certain conditions after session timeout, an immediate login would render the main
menu invisible.
Minor cosmetic fixes on MPR PDF printout.
InstantGMP MES Release notes version 2.050.001 5/26/15
New Functionality:
New streamlined workflow for Material Specifications with less screens and the ability to
filter by “Approved” “Pending Approval” and “All.” *
Option to allow or disallow Finished Goods and WIPs on MPR Bill of Materials.
Ability to assign personnel a default role on the TPersonnel screen.
Ability to sort BPRs by (descending) issuance time date stamp.
Improvements:
Reports are now integrated into IGMP with better functionality and minimal lag time.
QuickBooks Data Transfer Tool official release and improved P.O. report.
Fixes:
Product and Material traceability reports now pull all relevant data.
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Manual-3.000.001
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Sorting on Material Name on Material screen now works properly
Sorting on Clients on Project screen now works properly.
Attachment names now always present.
InstantGMP MES Release Notes 2.046.002
Additional Functionality:
Data transfer to QuickBooks: Requisitions and Current Inventory
Added Avg Cost/Unit field and Account for Materials – QuickBooks
Report for Cost of Batch ingredients and manufacturing overhead
Added Costing functionality to BOM calculator
Material Types are pre-populated and chosen from a drop down box
Improvements:
Vendor name included on additional screens for easier traceability
Prevents inclusion of part # of FG/WIP in an MPR recipe for said FG/WIP
Requisition screen streamlined
Changes:
Vendors are now Qualified on the Vendor page and there is no need to create vendor groups.
Vendors are now tied to materials at the receipt level
Note: please change any personnel with ADM role meant to sign for PM or QM signatures to
reflect those roles, as the ADM and Site admin roles have recently changed and the ADM has no
signature rights and can only create new personnel. Contact your InstantGMP Support
Associate for screenshots or an Adobe Connect session if you are having difficulty doing so.
Note: IGMP now runs best in Chrome.
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CSVP – InstantGMP™ User
Manual-3.000.001
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User Manual Summary
This user manual is set up to use Process Flow Diagrams and a training exercise to illustrate
the functions and business rules of the InstantGMP™ MES and the InstantGMP™ VAPE
applications.
The training exercise will lead you through the procedures and data entry steps that will allow for
the production of a batch of encapsulated powder.
InstantGMP MES/VAPE/PRO/INV/MD is a database application designed to manage GMP
manufacturing of any FDA regulated product. It includes entry screens for documenting
personnel information, room activity and equipment histories, project and vendor information,
raw materials and test specifications, purchase orders and inventory tracking as well as Master
Production Records and Batch Production Records.
InstantGMP runs best in Chrome. Please download the free browser:
https://www.google.com/chrome/browser/desktop/index.html
InstantGMP runs on PCs and Macs as well as Windows based tablets (Full version of windows
not RT) and iOS.
Overview of Main Menu and Sub-menu choices
There are eight (8) Main Menu choices that reside at the left of the opening screen. Each of them
have additional sub-menus choices.
The following main menu choices are found to the left of the main application screen. They
contain sub-menu choices which are selected to enter in data. 1. Setup 2. Materials 3. Specifications 4. Requisitions 5. Inventory 6. Logs 7. Project 8. Batch Record 9. Audit 10. Reports
Sub-menus (signified by bold grey text e.g. Set-Up Personnel:) The main menu choices have
sub-menus from which to choose in order to complete various activities. For example, Set-Up
consists of sub-menus that open data tables. The Personnel table contains the names and contact
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information of personnel. The Vendor table contains the names and contact information of
various material vendors.
1. Set Up
a) Personnel
b) Vendor
c) Material Type (raw materials, components, WIP, Finished Goods, etc.)
d) Material Status (Approved, Quarantine, Rejected)
e) Storage Condition
f) Unit
g) Facility
h) Room
i) Bin
j) Equipment
k) Tests
l) Methods
m) Countries
2. Material (including Finished Goods, WIP, and Raw Materials)
3. Specifications
a) Add Material Specifications
b) View Material Specifications
4. Requisitions
5. Inventory
a) Material Receipt
b) Inventory Status (quarantined, approved, etc.)
c) Inventory Management
d) Depleted Inventory
6. Project
a) Project Definition (Project & Product information)
b) WIP/FG material list
c) Project (Client Information)
c) Project Personnel
7. Logs (use, cleaning, maintenance)
a) Room Log
b) Equipment Log
8. Batch Record
a) MPR Record Definition
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b) Batch Production Record
9. Audit
a) Audit Log
b) Audit Attribute
10. Reports
a) Current inventory
b) Inventaory
c) Inventory in Quarantine
d) Equipment CAL/PM Date
e) Production Lot Traceability
f) Vendor Lot Traceability
g) Low Inventory Levels
There is a set workflow inherent to the program so that the GMP checks and balances can be
carried out in real time; thus there is an order in which the training and test scripts must be executed
for success. The order generally follows the menu items from top to bottom.
Your trainer has access to the DBADM (database administrator) dashboard whereby they can
toggle on and off certain features.
Specifications may be turned off (Note: this feature is not meant to be turned on and off repeatedly)
inventory checks for Material amounts can be turned off
Allowance for same user to sign for log and batch record operator and verifier for those not ready
for full adherence to GMPs.
Abbreviations
Abbreviation Description
ADM Administrator (ambiguous role that has access to
personnel screens to get started with the
program)
BOM Bill of Materials
BPR Batch Production Record
CoA Certificate of Analysis
FG Finished Good
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Abbreviation Description
ADM Administrator (ambiguous role that has access to
personnel screens to get started with the
program)
BOM Bill of Materials
ID Identification
IT Information Technology
MPR Master Production Record
MSDS Material Safety Data Sheets
oWIP Outgoing Work In Process
PM Project Manager
PS Production Supervisor
QM Quality Manager
Req Requisition, Purchase Order (with no associated
cost )
WIP Work in Process
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Definition Glossary
Acceptance Limit: result requirement for passing test.
Administrator/ADM: the personnel who have full permissions (except no access to security) set
for MES modules of InstantGMP functions. An Administrator can always view and edit,
however, they are generally not part of manufacturing projects or teams. An Administrator must
be assigned to the system in order to add other personnel and set security.
Approval: Formal permission or sanction needed: signature.
Approved: Confirmed or sanctioned formally, by signature. For materials and products: passed
all specifications and is fit for use, distribution or sale.
Bin Location: location of materials as uniquely defined by further organization than room
#/name.
Batch size: Amount of a finished batch, to be associated with corresponding unit.
BPR: Batch Production Record; the unique and numbered documentation of the manufacture of
a specific production run or batch of product. The BPR will have a unique batch (production or
lot) number and the capture of weights, times, and other results will be specific to one instance of
following the included instructions.
Client: the person or company who is responsible for funding the project.
Close: close the web page without saving changes.
Company: Your firm, plant, or company name (as editable on the DBADM dashboard only; this
is displayed in the upper right hand corner of the application)
Conditional Approval: Confirmed or sanctioned formally, by signature, but with restrictions;
permission to use at risk but not to ship, or pending some specified action.
Confirm: close the web page with changes saved.
DBADM: Data Base Administrator; role in InstantGMP utilized by InstantGMP support
specialist to provide customer service and for QA tester to perform U/FAT/OP/OQ testing.
Formulation ID: number or name identifying the specific recipe, formula, instructions, product
strength, flavor, unit, etc. of a product; Client Product Code can be used as a base.
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Production Supervisor: the personnel role subordinate to Project Manager who is responsible
for overseeing InstantGMP production at the manufacturing site.
Product Code (lite): internal code for product.
In-Process Test: Testing or inspection of any ingredients or components of a product or WIP
during any production phase.
Instance: Customer-specific, secure, cloud-based Database of InstantGMP.
Instance Owner: the company who has been assigned a specific instance of the InstantGMP
data base and who has control of the personnel, materials, facilities, equipment, projects, logs,
specifications, inventory, batch records and security settings for that specific instance.
Insert: to add new record.
Inventory Manager: Role specifically for those who purchase the Inventory version of IGMP
with modified permissions to exclude Projects, masters and batch records and includes more
rights than an operator. (similar to a PM with QM rights for material handling)
Inventory Operator: Role specifically for those who purchase the Inventory version of IGMP
with modified permissions to exclude Projects, masters and batch records and includes more
rights than an operator.
Material: any component, excipient, reagent, active ingredient or drug product that is needed for
or manufactured by InstantGMP.
Material Type: The Physical form of a material.
MPR: Master Production Record, A written template for the recipe and manufacturing
instruction steps and other info necessary for completing manufacture product.
Operator: the personnel who use InstantGMP to perform warehouse and production activities.
Order: drop down which allows users to order the results of a summary screen by any column
header.
Outgoing work in process: Partially processed material that is either held for further
processing, sold to a middleman or distributor, etc. treated like a finished good in inventory
after processing if added to inv via the button on batch record.
Performer: User/operator who completed task.
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Personnel: Interchangeable with user, person assigned a name and password in the application.
Print: provide a hard copy or PDF copy.
Product Name: product to be produced, and for which to write an MPR.
Defined in the project by the concatenation of the material name, strength, primary container and
suffix.
Project: (MES only) precursor to creating an MPR, assigning a WIP or FG part number with
additional titles and associating with a client (differentiate the client/sponsors’ MPRs from other
projects.)
Project Manager: the personnel who have the InstantGMP responsibilities defined in the Project
Initiation SOP. They are generally in charge of the project team and administration for
manufacturing projects.
Production Supervisor: Operations manager at the floor level responsible for Production
Operators and Operations including log responsibilities.
Quality Manager: the personnel who have the InstantGMP responsibilities defined in the
Quality Management SOP. They are generally responsible for quality oversight and approval of
quality operations in manufacturing projects.
Quality Operator: Role allowing for more permissions than an operator for Quality control
analysts.
Quarantine: Isolate or put on hold; not for use until further notice, the status all received and
batch-created materials default to in InstantGMP.
Rejected: Not accepted, not allowed to be used.
Requisition: request/order for materials from vendors.
Save: to retain.
Screen/page name: Developer chosen screen names visible at bottom left of each screen. This
differs from the title of the screen which appears across the top left of each screen in large blue
lettering.
Specification: Set of parameters defining the tests and limits required for acceptance of a
material for use in production or for distribution or sale.
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Status: Standard state of Quality of a component, excipient, API, raw material, WIP or finished
Product; used to assess a material’s safety and conformance to applicable specifications.
Standards are Quarantine, Approved, and Rejected.
System Type: Status of a material, FG, WIP, Raw.
Test: name of the test or goal of a procedure.
Test Method: Description of how a specific test is performed, standard to follow.
Theoretical yield: Amount of product that could theoretically be produced from a recipe in the
MPR given no loss (via deviations, testing/samples, QA inspection rejects, normal operation loss
e.g. lost in air, residue on equipment, batch does not fill full integer of containers, etc.)
Title: User Functional Screen Title visible in Blue font in top left of screen.
Update: to modify a record; add, edit or delete.
User: The individual with a user ID and password.
Verifier: Personnel to sign for verification of a manufacturing step which a performer has
completed.
Verify: to confirm the truth or correctness of (something).
iWIP: Work in process; incoming goods that will be used as ingredients in manufacturing.
Icon Glossary
User Name and Role: A drop down in the upper right hand corner of the screen that lists the
roles that are currently assigned which user may toggle between.
Note: This feature is for convenience and special circumstances and should be used responsibly
and only within the scope of 21CFR part 11.
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Title: At the top of the page the screen name indicates what kind of data the system will display
in the current screen In the example, the title says "MPR Record Definition"
Direct Access Icons: At the upper-right part of the screen there are, depending on user rights,
three active icons:
o Password (change password)
o Favorite
o Home button (resets to see entire menu)
o Security (change user rights to the current screen) , and
o Logout (leave the application)
Pagination Buttons: The information in the grid is displayed in groups of usually 50 records. To
access the next 50, there are paging buttons:
The "First" button: , the "Previous" button: , the "Next" button: and the “Last"
button to access the chosen number of records.
The Qty of rows field allows users to adjust the amount of rows displayed on the screen. Enter
the number desired and select the icon.
In some cases there may be an “Add New Record” button, to add new records.
The Confirm button registers the entered data into the data base. The Close button closes the
screen and returns the user to the previous screen but does not save any changes in the database.
The Search button searches for the entered data. The Clear button clears all data from the search
function and resets the screen to include all data.
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The print button appears on several pages and allows the user to print an MPR or BPR.
A report for Material Specifications can be printed using the report button.
The “Copy Manufacturing Steps From Another MPR” button allows the user to select from a list
of MPRs from which to import the manufacturing steps.
The “Copy Materials From Another MPR” button allows the user to select from a list of MPRs
from which to import the materials.
The “Copy Equipment From Another MPR” button allows the user to select from a list of MPRs
from which to import the equipment.
The “Copy Tests From Another MPR” button allows the user to select from a list of MPRs from
which to import the tests.
The sign button comes in different forms and prompts the pop-up signature box. Performer,
Verifier, PM, QM, Approval signatures are all variants of the “sign” button and are seen
throughout the program.
The Choose File button allows the user to search for documents on his or her computer to attach
to a record. The attachment file Document Name link is available on the records once a file has
been attached. Selecting the hyperlink of the file name will prompt pop-up box for user to choose
what to do with selected file.
The Add Test button adds a line for tests methods and acceptance limits on the specifications
screen.
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The sort/filter selector: In the right collapsible search
panel there will be an option to organize the data on the grid. This drop down box allows
determining how the results will be sorted/filtered
The Show selector is available in the search panel on select
screens and filters for and shows only records that fall under the selected status.
Search /Clear: allows the user to search for records or to clear the current filters. There
are several possible scenarios regarding the use of the filters:
o If the user needs to find a particular record, s/he types the record name and clicks
search.
o If the user does not enter anything at all in the field, then the system will display all
available data, with a default of 50 records per page.
o If the user does not remember the complete record name, s/he can enter any part of it
and the system will search for all records which include the typed string.
o If there is more than one filter and the user enters data in more than one field, the
system will search information that matches ALL filters entered.
The Show drop down: shows only records with status of chosen option
The Data Grid: The area where data is displayed. In each line of the grid there may be
two or three controls:
o A hyperlink, indicated by blue text, which takes the user to the record detail.
o An Update pen Icon ( ) which allows the user to modify the record.
o In some cases there may be a version hyperlink; such as for a material or requisition
which will also be indicated by blue numbers. E.g.: Version: 2.
o The Copy (MPR versioning) icon can be seen on the MPR summary page and
makes a new, editable copy of the closed-out record.
o The version up icon allows user to make a sequentially numbered version of the
chosen MPR and can make changes to certain fields.
o The Scale up icon allows users to scale up the theoretical yield which automatically
scales up the BOM. If the auto populate button is checked, the scaled up amounts are
also transferred to the material action associated with the use of a material on
manufacturing instruction steps.
Note: The min and max are not automatically updated and should be checked.
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o User-selected data lists will include the choice to update or delete an item. The delete
icon will either instantly delete the record to bring up a pop-up screen asking user
to confirm the deletion. Select embedded tables have gray x’s for delete buttons.
o A printer icon to the left of completed records can be selected to print specific
records.
Data Entry “T” Screens
o Some screens will also include a material upload arrow which prompts a selection
list of materials to choose from as a separate pop-up screen. This icon can be seen on
MPR and BPR BOM pages, Project Definition, Manufacturing instruction Step, and
Requisition screens. These screens are data entry screens whose screen names always
begin with “T.”
o Blank checkboxes with dark blue outlines are available on several screens and
indicate that they can be selected; for example:
Note that some boxes (gray with gray checks) are visible from other screens, but they
can only be modified via screens whose names start with “T.” For example, the
HWWMaterialStatus screen shows a list of checkboxes whose statuses can only be
changed on the TMaterialStatus page after selecting the update pen icon.
The attachment file selection button appears on the Material receipt, Material status, MPR and
BPR cover pages as well as the manufacturing instructions of the MPR and BPR; It allows for
the attachment of a word, excel, jpg, or PDF file and is updatable (exceptions to update: after
MPR is locked, after receipt has been signed off and confirmed.) This button will allow the user
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to open existing attachments on material status, material use, material (bin) location, and MPR
and BPR covers.
The calendar icon allows the user to select a date from the calendar rather
than write it out.
Add Material Requisition button allows users to add lines to the requisition grid.
Change Location button allows users to change the location of a material vendor lot # via the bin
location.
The Update button appears on certain pages to allow the user to enter or change data on an
existing record.
The unlock function allows a QM user to unlock a previously locked BPR for the purpose of
adding memos regarding deviation investigations or adding stability data to an attachment.
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The Add Batch Inventory button allows the user to enter the amount of a finished batch produced
so that it can be tracked in inventory.
The Inventory button begins the workflow for a user to allocate use of a material in
real time during batch production via the batch record manufacturing steps or for more general
purposed via the inventory module. Bin location of material can also be accessed.
Manufacturing Process Overview
There are many QA checks and balances written into the program which guide an organized
workflow that follows Good Manufacturing Practices:
Starting a New Project
The checks and balances make quality a built in process that minimizes deviations and
omissions.
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Reference: SOP-101 Project Initiation
Optional features: Some features within InstantGMP are controlled in the background by the DBADM
dashboard. Contact your InstantGMP support specialist to toggle these features on and off:
1. QuickBooks Data Transfer tool 2. Ability to include FG and WIPs as ingredients in a Bill of Materials on the MPR. 3. Scanner Integration 4. Automatic Printing of Label on Receipt 5. Inventory Check Off 6. Specs Off (popular for VAPE) 7. Same person allowed on dual signature (popular for VAPE) 8. Medical Device View vs. MES view
Other optional features: 9. Increase user limit (contact [email protected]) 10. .Data import spreadsheet allows for import of vendor and material definitions (raw,
WIP and FG names) (visit instantgmp.com or contact specialist for excel file with instructions.)
STEP 1. Open your Instance of InstantGMP using your assigned Hyperlink to the secure
web address.
STEP 2. Sign in with your assigned UserID and password or with ADM user ID and
password to create a new user.
(This information is provided by InstantGMP support via email)
Set-Up
Adding Personnel
STEP 3. Navigate to: Set-Up menu Personnel
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Through this option a user shall have the ability to insert, update and search Personnel. The password
must follow a medium password strength policy.
STEP 4. Select Update pen for ADM.
STEP 5. Enter your e-mail for ADM.
STEP 6. Confirm.
STEP 7. Select Add New Record button to create a new record.
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STEP 8. Enter First and Last Name (Project Manager)
STEP 9. Enter “pass1233” for a medium strength password
STEP 10. Select Project Manager role from the Default Job Function dropdown
STEP 11. The Administrator Rights Permission set is granted by clicking the checkbox
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STEP 12. Click
STEP 13. To add badge information click for the person and select a start date of no
later than current date and an end date of a year from now. (the badge scanner
option must be selected for on the dashboard for the feature to appear)
STEP 14. Repeat these steps for the Quality Manager role
Application Rules:
First Name and Last Name are mandatory.
Only Administrators shall have the authority to grant and revoke the Administration permissions
set. Only Project Managers should be designated as users with AR rights. Project Managers
should not give Administrative rights to any other roles unless the specific person is trained in the
complete application and their project duties include updating administrative information.
Anyone without the Administrator credentials is prevented from making any changes to screens
that are within the Administration menu and its sub-menus.
User ID is automatically assigned by the program with the following formula:
First letter of first name
First seven letters of last name
Sequential number starting with 01. (if Jane Doe were to be added next, she would be
JDoe02)
UserID is not case-sensitive
A password of medium strength is required; (must include alpha and numeric characters.)
Password is case sensitive.
The default Role can be assigned from the personnel screen. Personnel may login immediately
after role assignment on this screen.
After confirmation of the personnel screen, the option to create a badge is available on the
TPersonnel screen and the option to print the badge is available on the HWW screen.
Vendors
STEP 15. Navigate to: Setup Vendor
References: POL-0302 Vendor Selection and Qualification, SOP-212 Program to Qualify Vendors
Users have the ability to insert, update and search for Vendors.
Note: Manufacturer using IMGP must be listed in the vendor table. When FG or WIP materials
are to be produced using InstantGMP Batch records, the vendor list is selected from to identify
the vendor of that manufactured FG or WIP.
Note: The company name entered on the DBADM dashboard will automatically populate as the
first vendor.
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Note: Information other than Company Name is not mandatory and can be filled in at your
leisure
STEP 16. Click
STEP 17. Enter “Training-Great Raw Materials” as a vendor.
STEP 18. Click
Client
STEP 19. Navigate to: Setup Client
Note: A Client is any company ordering/funding projects, and/or represents clientele for whom
your firm does manufacturing, holding, packaging or private labeling.
Alternatively, your firm may be a Client who holds/packages/labels WIP/FG from other
suppliers whom you are mandated by the FDA to procure MPRs and BPRs from in efforts to
trace raw materials to customers and vice versa. There are different ways to set up MPRs
depending on your firm’s role in the process.
Note: The Company added on the Dashboard is automatically auto assigned as the first Client.
STEP 20. Click
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STEP 21. Enter Client Name: Training
STEP 22. Select “United States” from the Country drop down box.
STEP 23. Click
Material Types
STEP 24. Navigate to: Setup Material Types
References: POL-0303 Material Control Requirements, SOP-302 Material Types
Through this option a user shall have the ability to insert, update and search Material Types.
An effective Material Control system is essential to ensure that material and components are procured,
received, approved for use, labeled including expiry date, coded, stored, transported and dispensed
according to documented procedures when InstantGMP™ is used.
Note: These names will be the only items available in drop down boxes when material types need to be
selected and are essential to optimal organization of materials within InstantGMP.
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When new “Material Types” are entered into the system, they must be further classified with a
“System Type.” The three “System types” in the system are Raw Material “RM”, Incoming
Work in Process “iWIP”/Outgoing Work in Progress “oWIP” or Finished Goods “FG” This will
differentiate types of materials in other screens of the application where the system type is not
displayed. This will be important for searches for materials in other data base tables. Only
“Work in Process” or “Finished Goods” material types will appear when a Part # is needed in the
Project Definition screen. Material Types that have a system type of “Work in Process” or
‘Finished Goods” will not be editable. The screen does not have the “update” button available
for these types.
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STEP 25. Click
STEP 26. Enter “Raw Material” in the Material Type Name field
STEP 27. Select “Raw Material” from the Type drop down box
STEP 28. Click
STEP 29. Click
STEP 30. Enter “Packaging” in the Material Type Name field
STEP 31. Select Raw Material from the Type drop down box
STEP 32. Click and repeat steps for the material types that apply to your
operation.
Note: Finished Goods is a preset option and does not need to be entered; however, customization
such as “Encapsulated Finished Goods” can be created for convenience.
Material Status
STEP 33. Navigate to: Setup Material Status
References: POL-0303 Material Control Requirements, SOP-304 Material Status
Through this option a user shall have the ability to insert, update and search Material Status.
Application Rules:
The system will always maintain the material statuses "Quarantine", "Approved" and “Rejected”
which cannot be deleted.
The system will allow entry of other material statuses.
If the “System Status” check box is selected, it locks the “Material Status” name which can then
not be updated, changed or deleted. If the checkbox is not checked, the user can update the
material status at a later time.
Anyone with Administrator rights can check the System Status box and lock in a custom name
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and Status indicator (Quarantine/Approved.) This ensures that should a custom status be created,
it will always be identified to a root Status; e.g. “QA retains; Quarantine” or “Ready for Shipping;
Approved.”
Note: “Is Quarantine” is used as a default to define the status when an incoming material is first
received or internally produced WIP of FG is logged into the inventory after production.
A Material Status of “Is Quarantine” prevents the material from being used in a production batch.
Only the material types in this screen will appear in drop down boxes for material approvals.
Optional: steps 29 – 36, adding customized Material Statuses.
STEP 34. Click
STEP 35. Enter “FG Retains/Stability” in the Material Status field
STEP 36. Select the “Is Quarantine” checkbox
STEP 37. Click
STEP 38. Click
STEP 39. Enter “Approved for R/D” in the Status field
STEP 40. Check the box for “Is Approved”
STEP 41. Click
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Storage Condition
STEP 42. Navigate to: Setup Storage Condition
Reference: SOP-412 Environmental Chambers and Storage
Note: “Storage Conditions” refer to the conditions that are available in the facility covered by an
instance of the data base. Only the storage conditions in this screen will appear in drop down boxes
when storage conditions have to be specified.
Through this option a user has the ability to insert, update and search Storage Conditions.
If there are stability chambers, cold rooms and warehouses, each condition should be entered.
The Storage Condition Name is a unique and required field.
STEP 43. Click for the “Ambient” selection.
STEP 44. If your facility has specifications for ambient room temperature such as: 18 C
45%RH, or 68-73 F, 44% RH, enter it here. If not, make no changes.
STEP 45. Click
Unit
STEP 46. Navigate to: Setup Unit
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“Unit” refers to units of measure that will be used in the purchasing of materials and in creating batch
formulas. The unit conversion feature enables the operators to purchase material in larger quantities (e.g.:
kg) and deplete the inventory in smaller quantities (e.g.: g).
Application Rules:
Only the units in this screen will appear in drop down boxes when units have to be specified.
Additional static units may be added by selecting the insert button and confirming a new
entry. These units will not be interchangeable nor will they convert from or to any other
unit.
The Unit Name is a unique and required field. (this only applies to additionally added units, which
for most companies is not necessary.)
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Facility
STEP 47. Navigate to: Setup Facility
Reference: SOP-404.01 Facility Start-Up and Shut-Down, SOP-401.01 Performance
Qualification of Systems (PQ), SOP-402.01 Facility Access and Security, SOP-403.01
Warehouse and Production Area Cleaning and Maintenance.
“Facility” refers to the buildings/Campuses where manufacturing/holding/packaging is to be
tracked in a single instance of InstantGMP software system. Through this option a user has the
ability to insert, update and search Facilities.
System Rules:
Only the facilities entered on this screen will appear in drop down boxes for specifying
facilities.
The Facility Name is a unique field.
STEP 48. Click
STEP 49. Enter Facility name “Training-Manufacturing Site”
STEP 50. Click
Room
STEP 51. Navigate to: Setup Room
References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and
Facility, SOP-406.01 Equipment and Room Logs and Status Tagging
Through this option a user shall have the ability to insert, edit and search Rooms.
Room refers to any numbered room or designated space used for storage/holding, processing or
packaging of materials and components, as well as any spaces used to support or facilitate those
functions or processes documented in InstantGMP. (e.g. weigh room, airlock, gowning room,
controlled hallways, etc.)
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Application Rules:
Only the rooms entered via this screen will appear in drop down boxes when rooms have
to be specified.
Every Room must be linked to a Facility. This is implemented via mandatory selection of
a Facility from a drop-down box to define a room.
Room number must be unique per facility. Room names can be used multiple times.
STEP 52. Click
STEP 53. Select “Training-Manufacturing Site” from the Facility drop down box.
STEP 54. Enter the room number 99900 and room name Z -Training
STEP 55. Click
Bin Location
STEP 56. Navigate to: Setup Bin Location
References: SOP: 420 Facility Maintenance and Modifications
Application Rules: Facility must be unique and is required.
STEP 57. Click
STEP 58. Select “Training-Manufacturing Site” from the Facility drop down box.
STEP 59. Select “99900-Z -Training”
STEP 60. Enter “102” for Bin Number
STEP 61. Enter “Samples” for Bin Location
STEP 62. Click
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Equipment
STEP 63. Navigate to: Setup Equipment
References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and Facility, SOP-
406.01 Equipment and Room Logs and Status Tagging
Through this option a user has the ability to insert, edit and search Equipment. The Equipment Code is a
unique field entered by the user.
Application Rules:
Only the equipment in this list will appear in drop down boxes when equipment has to be specified.
Equipment name and number are mandatory
STEP 64. Click
STEP 65. Enter in Equipment Number “999999” and Equipment Name “Training - Equip”
(required fields.) Add arbitrary numbers to model and serial number. Select
calendar and current date for due dates.
STEP 66. Click
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Tests
STEP 67. Navigate to: Setup Tests
Reference: SOP-215.00 Tests
“Tests” are the titles of the attributes, quantitative or qualitative, that will be used to determine whether
materials in question are in compliance with specifications. A Test names what is being tested for.
Application Rules:
Through this option a user shall have the ability to insert, update and search Tests.
Only the tests entered in this screen will appear in drop down boxes when tests have to be specified.
The Test Name is a unique field.
STEP 68. Click
STEP 69. Enter “Micro”
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STEP 70. Click
STEP 71. Repeat steps for more tests if applicable to your operation
Methods
STEP 72. Navigate to: Setup Methods
Reference: SOP-216.00 Methods
Application Rules:
“Methods” are the actual procedures that will be used when testing of materials is
required to show the materials are in compliance with specifications. A method is How to
test.
Through this option a user shall have the ability to insert, update and search Methods.
Only the methods confirmed via this screen will appear in drop down boxes when
methods have to be specified
The Method Name is a unique field.
STEP 73. Click
STEP 74. Enter Method associated with a test. “USP (62)” Note: a specific SOP #, procedure
#, or Assay name could be used here as well.
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STEP 75. Click
STEP 76. Repeat steps for more Methods that are applicable to your operation
Countries
STEP 77. Navigate to: Setup Countries
“Countries” identify locations where manufacturing/holding/packaging/labeling facilities are
located or where personnel are based.
Application Rules:
Only the countries in this screen will appear in drop down boxes when countries have to
be specified.
Through this option a user shall have the ability to insert, update and search Countries.
The Country Name is a unique and required field.
STEP 78. Click
STEP 79. Enter Country name. “UK”
STEP 80. Click
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Material
STEP 81. Navigate to: Materials
References: S308 Part # Assignment and POL-0208 Project Initiation
Through this option a user has the ability to insert, update, and search Materials.
“Materials” are parts and components for manufacturing or the products of manufacturing.
Material Classifications separate these two types of materials for ease and organization:
Incoming raw materials, components, packaging and labelling and incoming WIPs
Vs.
Outgoing WIPs and finished Goods (in house WIP counts as outgoing since it is manufactured
Note: The components, excipients, raw materials, incoming and outgoing work in processes and
finished goods WIPs are materials that are either ordered for further use in production,
precursors to products to be manufactured in-house or shipped to be further processed elsewhere.
Example: bulk powder herbal blends are FG for the blend manufacturer but are Raw Material for
the encapsulator. For the encapsulator, bulk capsules are WIP if packaging is done in-house or
FG if sent to a third party.
Application Rules:
Materials should only be ordered from approved/qualified vendors; see business rules on
Vendor Qualification.
Note: InstantGMP and applicable SOPs assume that all materials ordered are from
qualified vendors according to SOP-0212 – Program to Qualify Vendors.
The Part Number is a read-only and auto-numbered field assigned by the application
Material Name is a unique field. An error message will be displayed if a duplicate is
entered.
Products to be manufactured are automatically assigned Part #’s by the system prior to
production so these materials can be tracked by the system prior to and after
manufacturing.
Material Classification, Material Name, Type, Unit and Storage Condition are required
fields.
The Material Name will be a read only field after it is created.
In the Material Update screen shown below, the Material name cannot be edited.
Vendor number is akin to a catalogue number from a vendor; individual lot numbers are
entered later.
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The application will alert user with red error messages when any mandatory field has
been overlooked.
The selected Unit for outgoing materials should represent the Material units
required when creating the batch.
o Note: Take time to consider ordering unit, densities used in any calculations and
unit of sale item. This is a crucial step of the organizational process that can save
you consulting hours in the long run.
The search panel on the right includes a search for part #, material name, material ID and a filter
for Material type.
STEP 82. Click
STEP 83. Select “Raw Material/In-Coming WIP/Other” Material Classification
STEP 84. Click
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STEP 85. (Mandatory) Select the (Material Type) “Ingredient-RM” (See Figure 21)
STEP 86. (Mandatory) Enter the Material Name “Training-Raw Powder”
STEP 87. (Mandatory) Select the unit of measure associated with the material. “g”
STEP 88. Enter the Material ID “Training Raw 1”
STEP 89. Enter the Material Description “Fine white powder”
STEP 90. (Mandatory) Select Storage conditions from the dropdown box. “Ambient”
STEP 91. Enter a shelf life (based on stability studies, the limiting ingredients’ expiration date
or a default standard) “12 months”
STEP 92. Enter QM retest period (based on QA retain or stability test specifications) “12.000”
STEP 93. Enter a vendor order number if known (static number used from a supplier to
represent that material): “TrainingGRM-1”
STEP 94. Select Vendor from the dropdown box. “Training-Great Raw Materials” (Select
your own company for products produced or packaged in-house)
STEP 95. Click
STEP 96. Repeat steps 81 through 91 for “Training-Capsules” (See Figure 21)
STEP 97. Repeat steps 81 through 91 for “Training-Container” (See Figure 21)
STEP 98. Repeat steps 81 through 91 for “Finished Encapsulated Product FG” (See Figure
21)
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Note: For this material’s Select Material Classification Use “Finished Good/Outgoing WIP”
Material Type Ingredient-RM Component-RM Primary
Container-RM
Packaged/Labeled-
FG
Material Name Training-Raw
Powder
Training-
Capsules
Training-
Container
Finished
Encapsulated
Product FG
Unit g ea ea kg
Material ID Training Raw 1 Training Raw 2 Training PC Training Finish
Material
Description Fine white powder Clear, no band
vegetarian gel
White plastic
bottle
Encapsulated
Powder
Storage
Condition Ambient Ambient Ambient Ambient
Recommended
Shelf Life 12 months 12 months 120 months 12 months
QM Retest
Period 12 3 12 3
Vendor Order
Number TrainingGRM-1 TrainingGRM-2 TrainingHDPE
Vendor Training Great
Raw Materials Training Great
Raw Materials
Training Great
Raw Materials
Figure 21
Note: Confirmation will return user to the HWWMaterial screen with a summary of all materials
confirmed.
Material Specifications
Specifications for Raw materials including any components, labels, etc. or incoming WIPs may
be any tests completed to prove the purity, strength, identity or general physical properties and
fitness for use in production. This also includes any visual comparison to a known standard as
well as other organoleptic methods.
Specifications for outgoing WIPs and FGs produced in-house may also have specifications for
final purity and strength, retain and stability testing and in-process testing such as fill volumes or
weights of capsules, pH, uniformity of color or viscosity, inspection of containers, closures,
packaging and labelling, among others.
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STEP 99. Navigate to: Specification
The Material Specifications page “HWWSpecification” screen shows all specifications, allowing
for filtering for “Approved,” “Pending Approval” and “All.”
Application Rules:
The record is automatically assigned a sequential version number.
A user has the capability to insert, update and delete tests/methods/etc. for a Material
Specification until both the PM and the QA signatures are confirmed. No further changes
can be made after the PM and QM approvals are confirmed.
Part #s with an update icon indicate that the material specifications have not yet been
approved and locked.
A version 2 cannot be created until the version 1 signatures have been confirmed.
(A part # whose specification is open (not locked) will not appear on the “Select Part # to
version Up” screen (and a new specification version cannot be created) because the prior
version has not yet been approved and is still editable.) Open records will only appear on
the HWWMaterialspecification screen and can be seen by filtering for “pending
approval” or “ALL”
QM and PM approval is necessary for the Material to be used in the Bill of Materials of
an MPR, inventory, or projects.
If a material needs different specifications for different uses (e.g. lactose in a liquid
product vs. lactose in a powder product), a new material part number must be created and
assigned unique specifications.
Different versions of a material specification may be used concurrently in different MPRs
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This list is comprised of materials with specifications still pending one or more signatures and
materials for which specifications are completed and locked down.
Note: if you expected to see records on this screen but do not, select filter in the right collapsible
panel, for “ALL” to display those records.
STEP 100. Click to create new specification.
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This list is comprised of new materials without specs assigned and materials with signed off specs
for which a new specification record can be generated. If a material does not appear on this list, the
material has an open record that needs to be edited and/or signed. To access open records, select
the “Cancel” button to return to the hub screen and filter for “Pending Approval” or “All.”
Records with update arrows can be modified and signed and locked.
STEP 101. To create version 1, Click the for the “Training-Raw Powder” Material.
Note: Even if no data is entered, confirming creation of this record will move the record to the
HWWSpecifications screen for in process records awaiting approval.
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STEP 102. Enter the effective date or current date of the test specifications for the material.
STEP 103. Enter the MSDS/ Safety and Handling Data “Wear gloves and mask; handle and
store in cool dry environment”
STEP 104. Enter General Sampling instructions for the material “Use plastic scoop #3 to
aliquot 5 grams into each of three plastic sample jars. Secure lid and label”
STEP 105. Click Add test button
STEP 106. Select test “Micro” from drop down.
STEP 107. Select Method “USP <62>” from drop down.
STEP 108. Enter a Acceptance limit of “<0 CFU”
STEP 109. Enter a Sampling of “In Process Visual”
STEP 110. Select the box for Required for Release
Note: The box for release indicates that the test in question is required to meet specs before the material
or product is released for R&D, production use, distribution or sale.
STEP 111. Click
STEP 112. Log out
STEP 113. Login as PManager01
STEP 114. Select Signature prompt for Project Manager/Project Supervisor
STEP 115. Click
STEP 116. Log out
STEP 117. Log in as QManager01
STEP 118. Select Signature prompt for Quality Manager
STEP 119. Click
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STEP 120. Repeat steps for the remaining material part #s in order to set and approve
specifications for all materials needed for production including the finished good product:
Material Name Training - Capsules Training-Container Finished Encapsulated
Product FG
Effective Date Use current date Use current date Use current date
Safety/Handling Don gloves, keep cool
and dry
Don gloves, keep cool
and dry
Don gloves, keep cool
and dry
Sample Instructions Clean dry scoop/Close
and label with lot#,
personnel initials and
date/see methods.
Clean dry scoop/Close
and label with lot#,
personnel initials and
date/see methods.
Clean dry scoop/Close
and label with lot#,
personnel initials and
date/see methods.
tests Select a test and method
from drop down
Select a test and method
from drop down
Select a test and
method from drop
down
STEP 121.
Note: A New sequential version (2) may be created by clicking the hyperlink for part number on
the version up screen and repeating steps for a part number with an approved specification
version 1. Reason for change is required.
Creating a Project
Application Rules:
Your firm should be entered as a Client as well as a Vendor; this may be accomplished in
one step by having your support specialist (the DBADM) enter your company into the
“Company” field on the DataBaseADMinistrator dashboard.
Project Definition
STEP 122. Navigate to: Project
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STEP 123. Click
Application Rules:
The Project Title is a unique and required field.
The Project Title is read only once the Project is created.
Only parts that are “oWIP” or “Finished Goods” can be selected in the Part Number field.
Multiple part numbers may be selected for a single project.
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Multiple products built on the same part number are allowed per project
STEP 124. Enter the Project Title “Training -Finished Encapsulated Product”
STEP 125. Enter a Project description (optional)
STEP 126. Select WIP/FG Part # Tab
STEP 127. Click
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STEP 128. Click for “Training - Finished Encapsulated Product FG”
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STEP 129. Enter Strength
STEP 130. Click for the Primary Container part # selection list
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STEP 131. Select the hyperlink for the Primary container
STEP 132. Enter a Product Name Suffix (optional)
STEP 133. Click
STEP 134. Select the Client tab
STEP 135. Add secondary client if applicable
STEP 136. Select the Personnel tab
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Note: Delete personnel from the project or add personnel to the project using
button
STEP 137. Click to add a secondary role for the PM
Application Rules:
Each person must be assigned a Job Function in order to log into the application. (Until a
primary role is assigned on the TPersonnel screen,, the application has no permission
boundaries set for that person; the default is no permission set and the person cannot get
to the main menu) See Personnel page for other options.
Personnel can be assigned different roles for different projects.
Personnel can be assigned multiple roles per project.
A person can be an MPR Approver and/or a BPR Approver, or neither.
Each Project should have at least one MPR and at least one BPR approver assigned.
STEP 138. Click
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STEP 139. Select Quality Manager role from the drop down
STEP 140. Click
STEP 141. Select update icon for PManager01
STEP 142. Select the MPR and BPR checkboxes
STEP 143. Click
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Requisitions
STEP 144. Navigate to: Requisitions
Through this option a user can create a material requisition with multiple materials from the
same vendor.
Application Rules:
The system will allow a user to build a requisition using materials from a single vendor.
One and only one vendor is identified per requisition.
Only approved Material Specification versions will appear in selection list
The Part Number, Unit, and Qty fields are required fields for each line of the requisition.
Unit chosen must be equivalent to or convertible to the unit assigned to part # on Material
page
Amounts ordered for a material requisition can be converted to other units within that
unit system but cannot be converted from weight to volume or vice versa.
The system will assign a unique requisition number for each requisition created.
Once a Requisition is signed and confirmed it cannot be edited. The system will display a
print icon yielding a PDF version of the requisition
No update icon will be displayed when the record is no longer editable.
STEP 145. Click
STEP 146. Select the Vendor “Training-Great Raw Materials”
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STEP 147. Select needed by date (Today’s date)
STEP 148. Click
The Select Material Specification pop up will appear
STEP 149. Select “Training - Raw Powder” (popup is closed automatically
STEP 150. Enter Qty “3.010”
STEP 151. Select the unit kg from the unit drop down box.
If not already present, Enter “TrainingGRM-1” in the Vendor Order Number field.
STEP 152. Make sure to check the boxes for MSDS and COA. (Material Safety Data Sheets
and Certificate of Analysis)
STEP 153. Click
Repeat steps 142 through 147 for Vegetarian Capsules as seen below:
STEP 154. Click at the bottom of the page
STEP 155. Enter credentials and confirm.
STEP 156. Click
Vendor Material Name Unit Quantity Vendor Part
Training Great
Raw Materials
Training Raw
Powder
kg 3.010 Training-
GRM-1
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Training Great
Raw Materials
Training
Capsules -
Vegetarian
ea 1000 Training -
GRM-2
Training Great
Raw Materials
Primary
container
ea 100 TrainingHDPE
STEP 157. Select the printer icon on the requisition screen.
STEP 158. Print and or email electronic copy of the Requisition Order to Project Manager.
(Functionality will depend on version of Adobe)
Regardless of the accompanying software, the printout will appear as below:
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Inventory
This module includes Receipt, Status update and Use of a material.
Material Receipt
STEP 159. Navigate to: Inventory Material Receipt
Application Rules:
For each line (Part #/Material) of a requisition order, the system shall create a unique
Receipt Number for each material received per requisition which is auto-numbered and
read-only. This number is created at the time of requisition confirmation.
A digital signature is required to save a material receipt record.
The system will allow a user to record the receipt of a specified quantity of material,
which is added to the inventory upon confirmation of signature.
The system will allow a user to search for a material based on either Part Number,
Receipt Number, requisition number or material name.
The system will allow a user to record inventory usage details for each receipt number in
the system.
Through this option a user can search all the material that was ordered and ready to be
received as well as any partial records awaiting signature confirmation.
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STEP 160. Click for a part number to receive
STEP 161. Select the MSDS and COA checkboxes indicating that the data was received.
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STEP 162. Enter the Qty received 3.010
STEP 163. Select the unit received
STEP 164. Enter Vendor lot # “Training 2,” representing the specific lot received.
STEP 165. Select calendar icon and select today’s date for date received.
STEP 166. Select calendar icon for “Use by” date; select one year from now by selecting double
arrow icon and selecting date.
STEP 167. Attach any COAs or MSDSs via the “Choose File” buttons.
STEP 168. Click
STEP 169. Enter credentials
STEP 170. Click
STEP 171. Repeat steps for the remaining part number receipt Vegetarian Capsules.
Vegetarian Capsules Primary Container
Qty Rcv 1000 100
Units ea ea
Vendor Lot Number Training-GRM 2 TrainingHDPE
Date Received Use current date Use current date
Use By One year from current
date
One year from current
date
Application Rules:
Qty received, date received and vendor lot number are required fields
Upon confirmation of a material receipt record, that receipt# is no longer available on the
receipt screen
Upon confirmation of a material receipt, the record becomes available in the Material
Status section with a default status of “Quarantine” and on the Material use screen.
Inventory Status
STEP 172. Navigate to: Inventory Inventory Status
Application Rules:
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Only a Quality Manager (or inventory manager in the INV system) can change the status
of received inventory.
Any updates require a digital signature and will always display the UserID/time/date
stamp from the latest confirmed update.
The default value for all materials is Quarantine.
The Inventory Status screenshot shows the record created for a material received.
STEP 173. Select the Receipt number hyperlink
STEP 174. Logout and log back in as a QM OR toggle to the QM role in the upper right hand
corner of the application.
STEP 175. Click
STEP 176. Expand the Status drop down box and select Approved
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STEP 177. You will be redirect to a page to enter credentials and confirm
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STEP 178. Write “Training- All tests passed, see attachment” in the comment field
STEP 179. Select the browse button and attach a document to represent test results.
Note: the hyperlinked file names can be selected to bring up an open/save window for the previously
attached document.
STEP 180. Click
STEP 181. Repeat steps for Vegetarian Capsules and Primary Container.
Inventory Management
STEP 182. Navigate to: Inventory Inventory Management
Application Rules
Once a material is received in Material Receipt, the received quantity is populated in the
Quantity Rcv field expressed in units from receipt screen.
Qty remain will be expressed in units from the Tmaterial screen
A record will be created for each Material received in Material Receipt
A quantity greater than zero must be entered..
A user shall have the capability to remove/deduct (edit) material amount from each
Material Receipt Line with Quantity available.
The system will display the history of inventory usage records and the inventory balance
for each receipt number.
The system will allow a user to enter an inventory usage record using convertible units
(i.e.: g/mg; mL/L) and properly record the inventory balance in the default unit for that
receipt.The Project Manager will need to reconcile the inventory manually if multiple
sub-shipments of a material with the same lot number are received in the same day. If a
material is received on a single receipt with multiple sub-lots with different lot numbers
(split lots), then the Project Manager will have to create another requisition and a
subsequent receipt for each of the sub-lots.
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STEP 183. Select the receipt number hyperlink for a part number.
STEP 184. Click
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STEP 185. Enter “1.0” in the Quantity Used field
STEP 186. Select “g” from the Unit drop down box
STEP 187. Enter “Training Exercise- Testing” in the Purpose box
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STEP 188. Click
STEP 189. Enter credentials and confirm
Optional: Select gray attachment button or attach another document.
STEP 190. Click
Inventory Location
Inventory Location allows users to assign and change the location of an entire material receipt’s
vendor lot#/material/amount/unit via the bin location tied to a facility and room.
STEP 191. Click receipt hyperlink for material
STEP 192. Click
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STEP 193. Select the Facility, Room and Bin Location from the drop downs
STEP 194. Sign and Confirm
Depleted Inventory
STEP 195. Navigate to: Inventory Depleted Inventory
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Application Rules
Materials with a 0 balance will be in this list.
The page is Read Only.
Through this option a user can view, order and search all the Material Receipt lines with
no Quantity available.
STEP 196. Navigate to: Logs Room Log
Through this option a user shall have the ability to insert, update and view the log entries of the
Rooms and Equipment defined on the corresponding Administration screens.
Note: The room name can be a number.
STEP 197. Select Room # hyperlink for Facility
STEP 198. Click Enter:
Facility Training - Manufacturing Site Room Name Z - Training Activity Room Cleaning Cleaning Agent, Lot # Alcohol solution, Lot #222 Prod Name or Part # n/a Batch n/a Temperature 18 C Relative Humidity 45% Comments Room cleaned according to SOP CLN-002
Note: Temperature and humidity are only relevant if the room is supposed to be controlled.
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STEP 199. Select Operator Sign button, enter credentials and confirm.
STEP 200. Sign in as a QM
STEP 201. Select Review signature button, enter credentials and confirm.
STEP 202. Click
STEP 203. Navigate to: Logs Equipment Log
Equipment Log screen:
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Note: Start Date, End Date, Cleaning Agent, Product Name or Part # and batch refer to the
previous batch run in the equipment unless the cleaning is a periodic cleaning or not associated
with a batch. This is controlled by your facility’s SOPs.
Note: Equipment numbering convention to consider: YYY-XXX where YYY is the alphabetic
acronym for the equipment and XXX is the sequential number of that type of equipment for that
specific item.
STEP 204. Select Hyperlink for Equipment number
STEP 205. Click
STEP 206. Enter data as shown below:
Equipment Number a Equipment x Activity Calibration Start Date/Time Use current date and time End Date/Time Add 4 hours to above Cleaning Agent, Lot # n/a Prod Name or Part # n/a Batch n/a Comments Equipment calibrated according to Equipment SOP
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STEP 207. Have an Operator and Project Manager each sign for the activity.
STEP 208. Click
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Master Batch Records
STEP 209. Navigate to: Batch Record -Master Production Record
Through this option a user can add, edit, view, search, sort and hide, copy, version up, scale up
and print Master Production Records or Master Device Records.
To use the new Hide function, select the checkbox for those records you want hidden and confirm. To see
those records, select “Hidden” from the search Status drop down as search. To see only active records
select “Active.” “All” displays all records.
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Application Rules:
Project Title, Product name, Client, Author, Formulation ID, and Theoretical Batch Yield
and Unit are mandatory
The Product Name is tied to the project title and is a concatenation of Product name,
strength, primary container and suffix.
Bill of Materials, Equipment, In-Process tests, and manufacturing instructions are all
editable via the MPR tabs until a record is locked down
is used to edit a record
is used to delete a record
Approvers are assigned responsibility of approving MPR records via checkboxes on the
Project Personnel page and must sign for an MPR in order to create Batch Records from
the MPR.
Approvers can be edited via the Project Personnel Tab under projects
Upon confirmation of first assigned MPR approvers’ signature for MPR approval, the
record is locked down
Another required approver may unlock an MPR to make edits, at which point the first
signatory must sign again for the new changes.
Note: if only one signatory is assigned, the first approval locks the record for good.
Only one signature for reject will reject and lock the batch
A new version and/or a copy of the rejected batch may be created
An MPR, including attachments, will be read-only once all assigned MPR Approvers
approve the record.
Each MPR can have multiple versions.
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MPR versioning is controlled by signatures and a version button ; a version must
have the same Project title, product name, formulation ID, Theoretical Batch size,
strength (if applicable) primary container (if applicable) and BOM list amounts and units.
A Copy of an MPR must begin with a change in one or more of the following fields:
project title, product name, client, formulation ID, and Theoretical Batch yield.
Once an MPR or version copy has been created, it cannot be deleted but may be hidden.
In order to use the scale up functionality , the MPR used as a template must have had
the “Auto populate BOM Qty on Mfg. instructions” checkbox checked.
The “Auto populate BOM Qty on Mfg. instructions” checkbox can only be used to auto
populate the BOM quantities on the manufacturing instruction “Actions” when each
material in the BOM is used in the batch and the entire amount/unit Qty designated on the
BOM is used in one step.
Note: according to the FDA, An MPR is a Master template for Batch Records; a batch
record must be created for each and every time the recipe/instructions detailed in the
MPR are followed for batch production.
The scale up feature will scale up/adjust the material amounts on the BOM
The scale up feature will scale up/adjust the material amounts on the Manufacturing
instructions but NOT the min and max values, as the system does not assume that
doubling the amount would double the parameters.
Theoretical Batch yield is a read-only display of the theoretical yield as shown on the
cover page. This will be updated when the scale up calculator is used.
Users have the capability to select materials to be used.
For each chosen material, a unit must be chosen.
Changes can be made until MPR is approved and locked or rejected.
The “Quantity Required” refers to the amount of each part# that will be staged for
production. This can include components, filters, bottles, capsules, caps, packaging
labels, etc.
“Composition” refers to the amount of material that will be within a set unit of the final
product when manufacturing is completed. (e.g. mg/mL, mg/capsule, g/serving, etc.)
Copy materials from another MPR button allows user to select MPR from which to copy
all materials amounts and units.
Delete all button deletes all records on that screen including those not copied from
another MPR.
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Master Record Cover Page
STEP 210. Click
STEP 211. Select Project Title: “Training-Finished Encapsulated Product” from dropdown
menu.
Note: Version will auto-populate upon confirmation of page.
STEP 212. Enter the following information:
Project name* Training-Finished Encapsulated Product
Product Name* Finished Encapsulated Product FG-
Client* NEW
Author* Project Manager
Formulation ID* Dry Run Product Strength** 14 Theoretical batch
yield*
1002
Batch Size 1000 BPR Unit * kg Primary Container**
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Amount/Primary
Container
Primary Container
Amount Unit g
# of Containers 10
Purpose Training Supplement, Digestive health Scope Dry Run Attachment select “Browse” button and select an excel, word, PDF or jpeg file
* required
** populated with product name if identified during product name
STEP 213. Click
Master Record: Bill of Materials
STEP 214. Navigate to: Materials (Bill of Materials Tab)
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STEP 215. Click
STEP 216. Click to select a material
STEP 217. Select part # hyperlink for “Training-Raw Powder” for version 1 from list
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STEP 218. Enter data from table below into fields:
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STEP 219. Click
STEP 220. Repeat steps for Vegetarian Capsules, Primary Container
Material/Part#
Training
Raw
Material
Training
Vegetarian
Capsules
Primary
Container
Quantity
Required 3 1000 100
Unit kg ea ea Composition 3 1 3 Comp. Unit g ea ea
The Copy Manufacturing Instructions button allows users to copy BOM materials amounts and
units from selected MPR.
Master Record Equipment
STEP 221. Navigate to: Master Production Record Equipment
Application Rules:
Users have the capability to add delete and copy equipment to be used.
Changes can be made until the MPR is approved or rejected.
STEP 222. Click
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STEP 223. Select x(a) from drop down box
STEP 224. Click
STEP 225. Optional: repeat for Scale or other equipment entered from drop down
Master Records In-Process Tests
STEP 226. Navigate to Master Production Record In Process Tests
Note: these steps may alternatively be integrated into the manufacturing instruction
steps.
STEP 227.
Application Rules:
Users have the capability to add, copy and delete in-process tests that must be performed
during batch production.
Test and Method fields are required fields.
Changes can be made until MPR is approved.
STEP 228. Click
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STEP 229. Enter 1.00 for test number
STEP 230. Select “Micro” from the Tests drop down
STEP 231. Select “USP (62)” from the Method drop down
STEP 232. Enter “Check for defects” in the Test Purpose field
STEP 233. Enter “<5% failure per batch” in the Test Specification field
STEP 234. Click
Master Production Record Manufacturing Instructions
STEP 235. Navigate to: Master Production Record Manufacturing Instructions
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Definitions for Manufacturing Instruction Screens:
Step Number: numerical identification manually assigned to a manufacturing instruction
so that the system can sequentially order the instruction steps.
Part # upload arrow: If a component or material is to be used for completion of a step, it
can be added by using the prompt arrow to display the Part # selection screen
Version #: the version number of the required Part # has to be selected to assure the
material with the proper specifications is used.
Inventory: If a material is to be used in this step, select the “Inventory” check box. This
will alert the operator during batch manufacturing to enter the amount of material that is
used at that step and this will decrement the amount from inventory in real time.
Performer: If a signature of the activity performer is required at this step, select the
check box.
Verifier: If a signature of a verifier is required at this step, select the check box
Material Action: shows action as “Measure (amount/unit/) of (material name)” (smart
field updated with scale up if auto pop check is selected)
Action: the instructions for operators to follow in order to complete the step
Range: If an activity requires a measurement, then a range of acceptable values can be
entered.
Target: (smart field updated with scale up if auto pop check is selected) an activity
requires a measurement, then a target value can be entered.
Min: (smart field) numerical entry for the minimum allowable Qty for step with material.
(associated with Unit)
Max: (smart field) numerical entry for the maximum allowable Qty for step with
material. (associated with Unit)
Unit: Unit of measure tied to the Target and Range, Min and Max.
Attachment: word, excel, PDF, jpeg file attachment e.g. SOPs, device spec drawings,
spreadsheet formulas, forms, links to videos, COAs for material lot used, workflow
diagrams, pictures of machinery, etc.
Application Rules for MPR Manufacturing Instructions:
MPR Version is a read-only field.
Steps will be sequentially ordered (ascending)
Part number upload arrow displays a material selection list based on the MPRs Bill of
Materials.
If Performer and Verifier checkboxes are checked in the MPR manufacturing step, then
those same boxes will automatically populate in the BPR, prompting mandatory digital
signatures.
If the inventory checkbox is checked in the MPR manufacturing step, then that same box
will automatically populate in the BPR, allowing the user to deplete an amount in
inventory Associated with that step.
If the Auto populate BOM QTY on Mfg. Instructions is checked on an MPR cover,
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o The BOM amounts and associated units will populate actions on the instruction
steps.
o The approvals tab will display error messages when material part #s included on
the BOM are not included in a manufacturing instruction step.
o The approvals tab will display error messages when material part #s included on
the manufacturing instruction step(s) are not included BOM.
o The approval tab will display error messages for any materials in the BOM that
were identified in more than none manufacturing instruction step.
o The MPR manufacturing instruction steps will display error messages if the target
defined in the BOM is not within range of the min and max entries.
Data that is not confirmed will be lost. Always confirm data in fields before navigating
via hyperlink or button to other functions.
STEP 236. Click
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STEP 237. Enter “PREP” in the Action field
STEP 238. Select the “---” for the Unit dropdown
STEP 239. Click (Step will be labeled “0”)
STEP 240. Click
STEP 241. Enter data as below:
Step 10
Unit “---”
Action “Check room log for
cleaning of prep room
according to SOP-CLN-
xxx”
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STEP 242. Click
STEP 243. Click
STEP 244. Enter 20 for the step number
Note: it is best to leave numerical leeway between steps for possible additions during editing or
in later versions of the MPR
STEP 245. Select the upload arrow
STEP 246. Select “Training-Raw Powder” from the Selection list (version # auto-
populates)
STEP 247. Select checkboxes for Inventory, Performer and Verifier
Note: If the Auto populate Qty on BOM to Mfg. instructions was chosen on the cover page, an
action will appear automatically instructing the operator to “Measure out Qty/unit of material
part#”
STEP 248. Enter data as shown:
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Action Tare scale.
Record Scale Equip # and Calibration date.
Min .99
Max 1.2
Target 1.0
Range .99-1.2
Unit kg
STEP 249. Click
For Training purposes two steps are sufficient; however, if more practice is needed, one can
certainly use the examples below to create multiple steps and signature sets. Bear in mind that
each of the signature boxes checked must be signed for at the batch record level.
Manufacturing steps to consider for a GMP MPR include:
Counting and verifying labels – expiration date, product name, country of origin, dosage
or recommended scope, any mandated info (e.g. for dietary supplements signifying
product is a Dietary Supplement; not intended to cure treat or prevent disease; not
endorsed by FDA)
Checking Cleaning room logs,
Checking equipment cleaning logs and calibration dates
Obtaining line clearance from QC (environmental testing) or operators (debris and last-
batch labels cleared away/cleaning)
Staging materials (checking statuses, writing lot numbers and expiration dates, moving to
weigh station, cleaning, prepping utensils and bags/bowls)
Calibrating, tare weights, calibration dates of Scales/ recording
Turning on filters, air controls, water skids, machinery
Individual steps for operators to follow in order to run any of the machinery
o Time to do so
o Speed/level/
Gowning/Donning PPE safety equipment – gloves, respirator, booties, hairnets etc.
Weighing – actual weights recorded, each ingredient needs 2 signatures (controlled step)
Mixing- methods and tools
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Recording times of holding, mixing, heating,
Recording environmental factors; temp, humidity
Reconciliation of bottles, caps, labels, as well as FG/WIP samples/retains, rejects
In-Process Testing-
o visual uniformity checks; blended powder, dissolved solution
o pH, viscosity,
o Micro, Chem or other test samples set aside, etc.
o QA inspection of capsules/bottles/seals/label placement,
o Average weights of capsules/fill volumes, etc.
o Packaging instructions, from label to pallet
Note: for each step; decide what the risk to consumer safety or business reputation is for that
action not being completed correctly and mandate performer and verifier signatures
accordingly. Controlled steps such as exact weights or times or those requiring calculations
should always be checked for both signatures to be compliant with FDA regulations.
Master Record: MPR Approvals
Navigate to: Master Production Record MPR Approvals
MPR Approver names and associated roles with the options to sign for approve or reject are
displayed.
Note: Error messages specific to steps and or material part #s will appear for authors and
approvers to see before attempting to sign. These errors pertaining to inventory use must be
resolved before an MPR can be approved.
STEP 250. Select the Sign button for approve
STEP 251. Sign with credentials and confirm
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STEP 252. (log out and log in as another signatory) Sign with the unlock button to
unlock the record; write in a reason for unlocking the record in order to
proceed.
STEP 253. Make a change to one of the manufacturing instructions or add or delete an
instruction.
Note: Signature for first approval and first signature for unlock are logged and
the Approve and Reject buttons are available to all signatories.
Application Rules for MPR Approvals:
Users that have been identified as “MPR Approver” via checkbox on the Project
Personnel screen will populate the MPR Approval screen. (Note: this defaults to none; all
the PMs and QMs in the system for each new project are assigned )
Once one approval signature is confirmed, the entire MPR record is locked but can be
unlocked by a second required signatory and the record can be updated. A reason for
unlocking the record is required.
Note: if only one signatory is assigned to a project, an MPR for that project will be
permanently locked upon first approval.
Any new updates create a new version which will copy the current version except the for
approval actions.
MPR must be approved before it can be issued/viewed/executed as a BPR.
All information previously entered into the MPR (except Approvers) shall be visible and
locked/un-editable to ensure each time a batch is made it is made using the exact same set
of instructions.
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Batch Production Record
STEP 254. Navigate to Batch Record Batch Production Record
Application Rules for Batch Records:
Through this option a user can add, edit, view, search, issue, perform, approve and print
BPR Records.
Batch records can be printed before, during and/or after completion of the record.
A Batch can only be created from an approved MPR (exception: Approval signatures) to
ensure that each time a batch is produced it is made using the exact same set of
instructions.
The system will assign a unique batch number to each BPR record.
Users may add in a legacy number for their batch records in the production # field
Cover Page, Materials, Equipment, In Process Testing and Manufacturing Instruction
tabs shall show all the information that was locked down in the corresponding MPR.
Cover Page, Materials, Equipment, In Process Testing tabs shall be read-only
All tabs are locked until the Issuance button is signed by QA
Issuance button prompts the application to check whether the materials in the
BOM/formula/recipe are*:
o in an approved state
o with signed off specifications
o from a qualified vendor (currently assumed by ordering process)
o available in sufficient amounts
Once the Batch has been issued, the Manufacturing Instruction tab allows for the entry of
step results in real time during manufacturing by operators
Once any required data is confirmed the status of the batch goes from issued to in-process
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Users that have been identified as “BPR Approver” on the Project Personnel page will
populate the Executed BPR Approvals screen.
The system will allow a user to create multiple Batch Production Record (BPR) copies
from an approved MPR.
*Exceptions are for those opting to toggle off specifications and/or inventory checks.
Batch Production Cover Page
STEP 255. Navigate to: Batch Record BPR Cover Page
Show drop downs allow user to see only records of a certain status:
Generated: A batch that has been created but not issued
Issued: A batch that has been issued but does not have a manufacturing date
In-Process: A batch wherein any data has been confirmed on any step
Locked: A batch that has one approval signature confirmed. (no subsequent unlocking)
Reviewed: A record with all required approval signatures
Added to Inv: A batch that has been added to inventory via the BPR cover page.
Users may show Hidden, Visible, or both hidden and visible records (all).
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STEP 256. Click
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STEP 257. Select “Training-Finished Encapsulated Product” from the Project Title
drop down box
STEP 258. Select “Training-Finished Encapsulated Product-FG-14-Primary Container”
from the Product name dropdown box
The form is auto-filled with information from the MPR.
STEP 259. Enter “Training Exercise” in the Production # field
STEP 260. Click
STEP 261. Click
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STEP 262. Toggle to or sign in with a QA role
STEP 263. Click enter credentials and confirm
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STEP 264. Click
Note: Production number is now locked down upon Batch Issuance via QM signature. This is to
protect traceability.
Certain items of the batch record are now editable using on the BPR Cover page
Note: Users may sort batch records by double clicking on the desired column name.
STEP 265. Select the Materials tab to view the Bill of Materials (read-only)
STEP 266. Select the Equipment tab (read-only)
STEP 267. Select the In-Process Tests tab (read-only)
The Cover Page also allows for attaching documentation and printing the
Batch Production Record.
Note: the cover page attachment approved in the MPR can be overridden at the BPR level.
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Batch Record Manufacturing Instructions
STEP 268. Navigate to: Batch Production Record Manufacturing Instructions Tab
STEP 269. Log out and log back in as an Operator
STEP 270. Click for Step 10
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STEP 271. Enter “Room was cleaned @ 0600 by JDoe with 70% alcohol lot 222” in
Result field.
STEP 272. Click
STEP 273. Navigate to: Batch Production Record Manufacturing Instructions Tab
Application Rules for Batch Production Record Manufacturing Instructions:
The system will allow the operator to enter data in select fields in the BPR manufacturing
steps.
The operator may enter results, comments and deviations on the manufacturing step as
needed and update any attachments as necessary.
The operator may access the inventory use records for approved material lots and use
inventory in real time.
The material lot numbers, amounts used and signatures for each use within a
manufacturing instruction step will be auto-populated in the step.
Confirming a deviation comment adds a new signature button for a mandatory QA
approval of the deviation
Signature buttons signify that signature is required
Records with missing signatures for performer verifier or QA approval shall not be
Approved nor sent for use in inventory.
For steps with materials and the inventory box checked at the MPR level for those MPRs
with the Auto populate box checked, the automated action step will display.
Error messages will be displayed when the inventory amount used is not within the min
and max parameters set at the MPR level and deviations will be automatically opened.
Material uses for the part number of the selected step will be displayed on the step after
confirmation of uses. Multiple uses will be added to total the amount used for the step
and displayed as converted to the unit chosen at the Tmaterial screen.
STEP 274. Click for step 20
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STEP 275. Click
Application Rules for Inventory Use:
If the inventory checkbox was checked in the corresponding step in the MPR, then the
box will be checked in the BPR, alerting the operator to deplete the specified amount in
inventory. An Inventory button appears
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Selecting the Inventory button will bring up the inventory sub-screen with the material
that is available for use. The inventory can be depleted at this step in real time.
Depleting inventory will require operator signature.
STEP 276. Select the receipt number hyperlink for “Training-Raw Powder”
STEP 277. Click
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STEP 278. Select current date from calendar popup
STEP 279. Enter 3 in the Qty field
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STEP 280. Select Unit “g” from the drop down box
STEP 281. Enter “Training” in the Purpose field
STEP 282. Click
STEP 283. Enter credentials and confirm
Note: if an amount outside of the min and max defined parameters for the step is
confirmed whether in one action or multiple actions, a deviation will be initiated.
STEP 284. Click
STEP 285. Click for “Performer Required”
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STEP 286. Enter credentials and confirm
STEP 287. Hand control to another user to sign using their credentials, or toggle to
Quality/PM/ role and enter credentials for verifier and confirm
STEP 288. Select the appropriate navigation option in the “Action after Confirm”
dropdown
STEP 289. Click
STEP 290. Sign for any additional steps entered as an option
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Application Rules for Manufacturing Instruction Summary screen
Yellow checks indicate actions are required
Red checks indicate an error which stops the workflow
Green checks indicate all required actions for that step are completed
No check indicates that the step only requires that a result be entered
Note: Make sure to use material first and always confirm your results!
Batch Record Approval
STEP 291. Navigate to: Batch Production Record Executed BPR Review
STEP 292. Select sign button
STEP 293. Click enter credentials and confirm
STEP 294. Repeat for each mandated signature
Note: Signatures for MPR and BPR approvals are UserID-specific, not role
specific, so you must be signed in as the user requested.
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Application Rules
The system will lock a BPR including all its data once all assigned BPR approvers have
confirmed their approval signatures.
The first signature confirmation locks a batch
The system will allow a user to create a PDF report of the BPR record.
STEP 295. Navigate to the BPR Cover page tab
STEP 296. Click
Application Rules for adding Inventory
The system will allow a user to add the material from a BPR to the inventory as a WIP or
a Finished Goods type material.
The system will assign a Receipt Number to any WIP or Finished Goods material that is
added to inventory. (Requisition numbers for in-house produced goods FG/oWIP will be
0 as they were not requisitioned but manufactured with a batch record.)
STEP 297. Enter 3 into the Qty
STEP 298. Verify that “kg” is the unit
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STEP 299. Click
STEP 300. Enter credentials and confirm
STEP 301. Click
Sale/Distribution of WIP/FG products
STEP 302. Navigate to Inventory Material Use
STEP 303. Select the update arrow for “Training - Finished Encapsulated Product”
STEP 304. Enter 1000 for the Qty Use
STEP 305. Enter “Sent to Distribution center” / “sold to…”
STEP 306. Select sign button and enter credentials.
STEP 307. Confirm
Audit Log
STEP 308. Navigate to Audit Audit Log
STEP 309. Enter your UserID in the person field
STEP 310. Select dates including today or dates of other data entry
STEP 311. Select types of access and screens and click search. Data appears
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STEP 312. Select Hyperlink for a URL
STEP 313. Navigate to Audit Audit Attribute
STEP 314. Select attribute from drop down and confirm
STEP 315. Select hyperlink for additional information
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Reports
Current Inventory, Equipment PM/CAL Dates, and Inventory in Quarantine are direct reports
that do not require entry of any additional data for the report to be run.
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Low inventory Levels Report requires user to select a below “stock %” on which to report.
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Traceability Reports require data to be selected before applicable data can be displayed. Select a
lot/production number to see what material lot #s were used to make the batch
Select a raw or WIP material to display all of the batches wherein that vendor lot # was used
Inventory value report assesses value through cost field
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Barcode
Barcode Scanning Functions: Personnel Badges/ Login and Material Labels.
(included in your subscription and must be toggled on by your InstantGMP support specialist)
Specs for barcode scanners: You may choose a standard USB or wireless scanner with a 3of9
font, which can be found online and in office stores for as little as $14 USD.
The two I tested with most are TaoTronics TT-BS012 and YHD 1100. The YHD is plug and play
and very inexpensive.
We recommend DYMO Label writer 450 and the “Badge Label” setting, DYMO labels #30857
Barcode scanner – Material Handling
Users can print a label with the status of a material and a barcode for each material receipt – at the Status
level. Go to the Inventory->Inventory Status. You can also ask your training specialist to toggle on the
feature to automatically print labels upon receipt in order to print all quarantine incoming material labels.
Select for a material receipt to be printed. Ensure that you select the correct printer and size the label
to the correct template. (this will vary depending on your version of adobe, printer, browser, OS, etc.) I
have chosen badge label.
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Select and scan the label. The Inventory Status page for that Receipt/Vendor lot#
will appear where the QM can change the status to “Approved.” A new label can be printed with
the new status for that Lot/Receipt number.
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Using inventory with the scanner
Select on Inventory Management -Inventory Use screen. Or Manufacturing instruction –
Inventory Use screen.
Scan the label. You can also type manually into the field and then select Scan button.
The Inventory Use screen for scanned receipt/vendor lot # will appear and operators may
manually enter how much material they used. Operators may manually sign or sign with their
badge.
Operators may sign with badge by scanning their badge on any signature screen or popup and
confirming. Remember to confirm record on main screen to save the signature to the record.
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To set up and print a badge, go to Setup->Personnel and select no earlier than today’s date for a
start date and an expiration date for the exp date. Select the “Create Badge” button.
Note: the option to create a badge only appears after the first time a personnel record is
confirmed. If this is a new record, go back into the record via the update icon and the option will
appear.
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Navigate back to the Personnel screen; select the print icon in the row for whom you’d like to
print a badge.
Return to any screen with a signature prompt and select the button.
Scan the badge.
Click
Additional training videos are available online at http://www.instantgmp.com/support
Additional remote training is available via Trainer’s calendar online,
http://www.instantgmp.com/support/appointment-request
or a quote can be requested via [email protected]