complying+with+cgmp+during+phase+1

8/2/2019 Complying+With+cGMP+During+Phase+1

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Approaches to Complying with cGMP

During Phase 1

Guidance for Industry INDs


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FDA Guidance for Phase 1 CTM

Provide guidance for producing Phase 1materials

Covers Investigational Drugs and

Biologics Establishes rules for applying quality

control principles

Facilitate Phase 1 trials while protecting

study subjects Covers small or lab scale production

Link to FDA Guidance
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdfhttp://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf


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Requirements - QC Procedures

Written procedures that are well defined

Equipment that is adequately controlled

Data from production, including testing,that are accurately and consistentlyrecorded


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Requirements - cGMP Documentation

Personnel and training

QC plan

Facility and Equipment procedures Control of Components

Written Procedures for Production

Change Control

Laboratory Controls Container Closure and Labeling Controls

Distribution Documentation


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Requirements - Record Keeping

Equipment maintenance and calibration

Production records and related analytical

test records Distribution records

All quality control functions

Component records Maintain records for 2 years after trial

completed


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GMP Batches in Non-GMP Areas

InstantGMP complies with FDAguidance for Phase 1 supplies.

CROs can do GMP work in sameequipment/lab as development work

Tox batch can be made GMP and usedin Phase 1 trial

Medical device developers can produceGMP finished products
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdfhttp://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdfhttp://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdfhttp://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf


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Scalable Solution

InstantGMP

From small developmentbatches

To full productionbatches


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cGMP: Challenges of Traditional Systems

R&D contract manufacturing is a complex process.

Wide array of regulatory requirements

Reality of dealing with continual changes as projects progress

High time and cost to set up quality system

Long cycle times for QA review and corrections

Training and compliance to SOPs is lengthy

Documentation coordination and data tracking is laborious

InstantGMP is our manufacturing service that has beenbuilt from the ground up to meet these challenges


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InstantGMP - A new approach to

contract manufacturing. Seamlessly incorporate everything necessary in

one place where it is visible all the time toeveryone via cloud-based application.

Provides flexibility, speed, real-time access toinformation.

Uses proven quality procedures and efficient

data flow.

Accelerates startup and rapidly reacts tochanges and delays without endangeringtimelines.


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InstantGMPTM

A unique R&D contract manufacturingservice that:Allows sponsors to view and interact with

manufacturing information in real time.

Can rapidly react to changes and delayswithout missing a deadline.

Because: It offers flexibility, speed, proven procedures,

access to real-time information and efficientdata flow at all points during themanufacturing process.


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InstantGMP - The Manufacturing

Application Foundation of CFR 21 Part 11-compliant software

and an all-encompassing, paperless qualitysystem

Internet-based infrastructure

Data is automatically visible to all decision-

makers at the same time

Eliminates delays created by traditional linearprocesses


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Comprehensive Solutions to cGMP

Information is automatically updated everywhere in the system,

Sponsors can access their projects from any Internet-connectedcomputer

InstantGMP

Production

Specs Purchasing

Inventory Training


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Advantages

InstantGMP

TM

enhances control, visibility,efficiency and compliance of the regulated

Life Science manufacturing process.

QASponsor

Project TeamPurchasing

Manufacturing

Cloud

Server


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ControlAutomated rules and entries, that are based on the SOPs, are

integrated in the system.

Some of the many features:

System assigns lot numbers upon receipt.

QA enters and controls raw material status based on QC Labinput.

Can only issue approved raw materials.

Reconcile Lot receipts, issues and returns.

Predefined values for entries in batch records.

Electronic signatures.

Issues Requisitions.

Limited access.


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Batch Production

Digital signature with date stampDrop down lists toensure accuracy

Control


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Visibility Available via the internet Review and sign records from any location

Access controlled by firewall protection

Manage access for employees, partners and sponsors

Manufacturing

Remote Site Remote Site

ANYWHEREANY TIME


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VisibilityReview all areas of batch record via tabs:Cover Page, Approvals Page, In Process Tests, Bill of MaterialsEquipment List and Manufacturing Instructions Steps

Review and update manufacturingsteps online


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Efficiency

QC, QA, Warehouse, Purchasing, Inventory and

Manufacturing activities and records are linked.


Standard specs, tests and vendors are reusable within thesystem

Create Purchase Orders for approved vendors

Receive materials and manage inventory

Automated Master and Batch Production Record copies

BOM created as part of record Inventory depletes as batch is being run

Documents are transmitted electronically and signedelectronically.


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EfficiencyVendors, Tests and Methods need to be added only once


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QA Compliance

cGMP compliance controls are built into the system.


Limited access based on user/role

Materials quarantine/restricted until QA approval

Required signatures at specified batch record steps

Component reconciliation

Training records

Specification version control

Complete automated audit trail


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QA Compliance

Materials need to beIn an approved status tobe used in batches

Materials need to have qualifiedVendors before being used in batches

Only a Quality Manager can update a materials status


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Process Flow

Preparation for Manufacturing

No

VendorQualification

API, excipientsand components

identified

YesPM Initiates

Project

VendorsQualified?

ProjectDefinitionCompleted

QualityManager

ProjectManager

SpecsApproved?

Assign Part #s,tests, methods,

Specs

Select Personneland Roles

Yes

QualityManager


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Process FlowMaterial Management

IssuePurchase Order

MaterialsIn DataBase?

SpecsApproved?

Tests In

DataBase?

VendorsIn DataBase?

Update DataBase

No

No

No

Yes

No


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Process FlowMaterial Management

Receipt atWarehouse Record into

InventoryReleased

Quarantine,Test &

Release

No

Available for Billof Materials &

ProductionYes

QualityManagerFacility

Manager


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Process Flow - Production

MasterProduction

Bill ofMaterials

ManufacturingInstructions

BatchProduction

ApproveBatch Record

QualityManager

FacilityManager

In ProcessTests

Equipment

Sponsor


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Quick Facts

Developed by the manufacturing andquality experts at PharmaDirections

Integrated internet based application

developed through Quality by Designapproach.

20 Core Standard Operating Proceduresbuilt in

21 CFR Part 11 Compliant

Product has been in use since 2004


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InstantGMPPharmaceutical Contract Manufacturing with a view

Suite of virtual GMP manufacturing systems Takes full advantage of cloud-based computing 21 CFR Part 11 compliant database with hard coded SOP

requirements

Streamlines entire process of producing clinical trialmaterials

Simplifies the documentation and approval procedures toreduce production lead times

Ideally suited to the global market place - manufacturingcan be done in any geographical region while all data

and intellectual property is securely stored in US basedservers

For more information, contact:[email protected]