pharmaceutical company facility presentation

MAKE YOU COMPANY PRESENTATION DURING AUDIT

Presented By :Palash Chandra Das.www.uscgmp.com (official blog)

Applicable for Sterile Pharmaceuticals

http://www.uscgmp.com/

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<PASTE ONE SIMPLE PHOTOGRAPHS OF YOUR COMPANY>

WELCOME TO XYZ Pharmaceuticals

<Add tag line if any>

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LogoLog on to www.uscgm

p.com_ Palash Chandra Das

ABOUT US

<Write brief description of your organization>

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Log on to www.uscgmp.com

_ Palash Chandra Das

OUR TEAM

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ORGANOGRAM MD

Technical Director

Plant Head

Head Engg.Head Production

Head HR Head Acc./Finance

Head QA Head QC

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OPERATIONS OR ACTIVITY OF SITE Development and Manufacturing of

Small Volume Parenterals Liquid injections ( Vial and Ampoule) Lyophilized Vials

Other Supportive FunctionsQuality AssuranceQuality ControlWarehouseEngineering

EHSHR & AdministrationsFinance Purchase

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SITE PLAN

SECTION AREA Sq.m

TOTAL LANDBLOCK X

BLOCK Y

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Add Site Master Plan

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GROUND FLOOR (PRODUCTION)Paste

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Add Other related layout

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GROUND FLOOR (WAREHOUSE)

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LIST OF KEY EQUIPMENTS Compounding Vessel (50L,100L,400L – Vial & 100L ,500L - Ampoule)Holding Vessel (50L,100L,400L – Vial & 100L ,500L - Ampoule)Washing Machine ( Ampoule / Vial )Depyrogenation Tunnel ( Ampoule / Vial )Ampoule Filling & Sealing MachineVial Filling & Stoppering MachineLyophilizer (with automatic loading and unloading system)Vial Sealing Machine Process SterilizerTerminal SterilizerAuto Inspection M/c ( Ampoule / Vial )Combi Labelling M/c ( Ampoule / Vial )Blister Packing M/cAuto CartonatorColwrap Machine

MANUFACTURING

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details

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_ Palash Chandra DasENGINEERING SERVICES AND

FACILITIES

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PURIFIED WATER SYSTEM SCHEMATIC

• Give simple water system plan with brief descriptions

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KEY FEATURES OF PURIFIED WATER SYSTEM Add key features and controllers

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WFI GENERATION AND DISTRIBUTION SCHEMATIC

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KEY FEATURES OF WFI SYSTEM Add key features and controllers

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KEY FEATURES OF PSG SYSTEM Add key features and controllers

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HVAC SYSTEM SCHEMATIC Paste

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KEY FEATURES OF HVAC SYSTEM Add key features and controllers

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KEY FEATURES OF BMS Add key features and controllers

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Add key features and controllers

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LogoKEY FEATURES OF COMPRESSED AIR

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ENGINEERING SERVICES AND FACILITIES

EFFLUENT TREATMENT PLANT

Technology : Capacity : Effluent : Monitoring : Sludge :. Bio sludge :

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SYSTEM CONTROLS

Quality Control Lab: Add details features

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QUALITY CONTROLPaste

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QUALITY CONTROLINSTRUMENTATIONS

SR.NO

INSTRUMENT NAME MAKE

1 High Performance Liquid Chromatograph Shimadzu2 Gas Chromatography along with Head

Space Analyzer (GC, Head space GC)Agilent Tech

3 TOC Analyzer with auto sampler Shimadzu4 FTIR with ATR technology Agilent Tech5 UV- Visible Spectrophotometer Agilent Tech6 Auto / KF -Titrator Metrohm7 Polari meter Rudolph8 Analytical Balance Mettler9 pH Meter & Conductivity Meter Mettler

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Comprehensive list of QC equipment

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QUALITY POLICY

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_ Palash Chandra DasQUALIFICATION

& VALIDATION APPROACH

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VALIDATION MASTER PLAN Philosophical document that describes the approach for conducting Qualification & Validation activity.

Prospective validation approach hence ensure quality from the very first step.

Approach: Risk based life cycle approach Impact Assessment & GMP Risk Analysis :Impact Assessment is carried out to determine the extent of

qualification requirement for the concerned equipments and Risk Analysis is carried out for all critical equipments/ systems (identified in impact assessment) as per ICH Q9 and ISPE guidelines & for Laboratory Instruments as per USP.

Qualification: Installation Qualification Operational Qualification Performance Qualification

The document states all elements of the Validation Program and presents the Validation Philosophy. It defines the responsibilities of the various functional groups in performing the validation activities.

The VMP covers the qualification / validation principles as well as the organization and nomenclature of the documentation. Furthermore, instructions for approval procedures of qualification documents are also included.

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Life cycle ApproachPaste

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Quality Risk Management Qualification

Process Flow

DirectImpact

Systems

User Requirement specification

GMP Risk Analysis

ImpactAssessment

Does system directly impact

product quality?Yes

DesignQualification

InstallationQualification

OperationalQualification

Performance Qualification

NO

Does system support direct

impact System?

Yes

Reduced Qualification

IQ & OQ or IOQ

IndirectImpact

Systems

NO

NoImpact

Systems

QualificationComplete

UserCompliance Document

Vendor Sheet commissioning

report

START

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_ Palash Chandra DasVALIDATION PLANNING

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IMPACT ASSESSMENT (Specimen)Paste

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Equipment criticality matrix

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The GMP Risk Analysis (RA) is one of the initial steps in qualification/validation and shall be performed to identify the scope and extent of the single qualification and validation activities needed to prove control of the critical aspects in design and functionality of a particular systems/equipment. RA is performed for systems / equipment which have been identified as “Direct Impact” systems. In the course of the Risk Analysis (RA), equipment component and / or process step of the concerned equipment or process was discussed and examined with regard to its GMP relevance. Possible failures that may have an impact on product quality were identified and the failures evaluated. The decisions (GMP critical “Yes or No”) is explained and tests and / or measures defined to prevent or reduce the occurrence of the identified possible GMP related failures. The risk analysis is done as follows;The risk is analyzed specific to the process related to the equipment to identify suitable design measures. These measures were listed in User Requirement Specification of the equipmentThe results of the RA, which are the tests and / or measures defined in the Risk Analysis, have to be followed up and integrated in the further qualification and validation steps, starting from Design Qualification (DQ).

GMP RISK ANALYSIS (ICH Q9) Paste a

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A typical Risk management process consists of following steps:

Risk Assessment: Risk Identification Risk Analysis Risk Evaluation

Risk Control

Risk Reduction Risk Acceptance

Result of Risk management processesRisk Review

RISK MANAGEMENT PROCESS (ICH Q9)Paste

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RISK ANALYSIS (SPECIMEN) Paste a

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USER REQUIREMENT SPECIFICATIONLog on to www.uscgm

p.com_ Palash

Chandra Das

A detailed URS is prepared based on the Risk Analysis covering all the GMP and safety features and requirements applicable for that equipment. It provides the basis for subsequent design and qualification. URS contains the following information –• Objective and scope• Equipment/ system description, operational requirements, Basic machine / system details product quality requirement and general cGMP requirement• Capacity / output requirements• Process parameter outline• Material of construction and surface finish requirement, wherever necessary• Control system requirement• Safety requirement & environmental conditions• Documentation requirement• Constraints

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APPROACH FOR DESIGN QUALIFICATION

Define Objective

Define Scope of theProtocol

Describe the equipment

Define Responsibilities

Functional specificationVerify compliance with

User requirementSpecification and RA

YES

Prepare and approveDQ summary report

IDENTIFICATION VERIFICATION

Comply RequirementNO

Take Corrective Action

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DQ (Specimen)

Design Qualification (DQ) is documented verification that the proposed design of the equipment, or systems provided by the vendor (FDS) is suitable for the intended purpose and is in compliance with the requirements mentioned in the User Requirement Specification and Risk Analysis. In DQ point - to- point verification of URS and Risk Analysis is done with the FDS provided by thevendor. This verification is done in a tabulated format with complete traceability and highlighting the points mentioned in the FDS.

S. No. Subject Acceptance criteria URS

Ref. No.RA Ref.

No.

Compliance in FDS

(Yes/No)

FDS Ref. No. ( _______________)

Comment/Deviation Ref.

No.

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INSTALLATION QUALIFICATION

• Documented evidence that the equipment/system has been installed properly

adhering to all key aspects of the installation, approved design intentions and

manufacturers' recommendation.• Identification and verification of GMP relevant documents.• Identification and testing of GMP relevant components (structure, devices,

measuring instruments, control systems etc)• Identification and testing of equipment installation parameters.• Identification of relevant SOPs• Verification of Risk Identified in RA to be checked in IQ

Based on the FDS provided by the vendor all the components are assessed for their criticality. All critical components identified during this Component Criticality Assessment are qualified in detail i.e. separate datasheet is prepared for each critical components. However all non-critical components undergo limited qualification. The points identified (to be verified in IQ) during the risk analysis shall be verified during IQ.

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OPERATION QUALIFICATION

• Verification of general function.

• Full loop calibration of instruments.

• Verification of control/computer system function as per GAMP 5.

• Specific tests i.e. verification of operating ranges.

• Training

• Verification of Risk Identified in RA to be checked in OQ

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COMPUTER SYSTEM VALIDATION (As per GAMP 5)

• Verification of major hardware component• Documentation of Software name and version• Verification of inputs and outputs• Verification of Alarms and interlocks• Verification HMI screens and operation• Verification of access control/security• Verification of interfaces• Verification of power and communication failure • Verification of backup procedure• Verification of Data integrity system in e-documentation software.• Verification of Printer and cycle printouts

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QUALIFICATION APPROACH FOR LABORATORY INSTRUMENTS

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Different approach has been adopted for standard laboratory test equipment based on USP for establishing the level of qualification needed.On the basis of the level needed instruments shall be categorized into three groups: A, B, and C, as defined below.

Group A: Group A includes standard equipment with no measurement capability or usual requirement for calibration, where the manufacturer's specification of basic functionality is accepted as user requirements. Conformance of Group A equipment with user requirements/ Data sheet shall be verified and documented through visual observation of its operation. Eg. magnetic stirrers, vortex mixers, and centrifuges.

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LogoIMPACT ASSESSMENT FOR LAB INSTRUMENTS (BASED ON USP)

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Group B : It includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer's specification of functionality and operational limits. Conformance of Group B instruments or equipment to user requirements is determined according to the standard operating procedures for the instrument or equipment, and documented during IQ and OQ. E.g. balances, melting point apparatus, pH meters ovens, refrigerator-freezers and water baths.

Group C: Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application. Conformance of Group C instruments to user requirements is determined by specific function tests and performance tests. A full qualification process shall apply to these instruments. E.g. UV Spectrophotometer, High-pressure liquid chromatographs, Gas chromatographs and TOC analyzer.

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IMPACT ASSESSMENT (SPECIMEN)Paste

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Impact assessment regarding qualification

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The PQ is the final stage of validation, which demonstrates the performance of the equipment/ system when challenged under simulated production parameters. PQ is designed to demonstrate that the equipment/ system is capable of producing results at a predetermined level of quality (specification), consistently.The PQ includes critical variable studies, for example, by stimulating conditions of upper and lower processing, processing at the operating limits of the equipment, or circumstances like worst– case conditions. The points identified (to be verified in PQ) during the risk analysis shall be verified during PQ.

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FACILITY QUALIFICATION

Facility Qualification is documented evidence that all the rooms of a GMP relevant facility are constructed as per the predefined civil design meets the required environmental conditions and all the required equipments & critical utilities are available.Protocol shall be prepared for the room qualification under which each room shall be subjected to the static and dynamic verifications against the approved layout and room book. Room shall be subjected to the following verifications:• Construction Features (room size, civil finishes (wall, floor, ceiling, wall floor interface, doors, windows, drain points etc)• Major Equipments and Utility supplies• Lighting (Light fixtures, switches and power sockets, illumination in the room (lux level)•Environmental Features (Class, AHU, filtration level, temperature, relative humidity, differential pressure, particle count as applicable Air changes, No. Of HEPA filters/ grilles)• Low voltage accessories (door interlocks, safety features, LAN, phone etc.)• Other FeaturesRoom environment (temperature, relative humidity, differential pressure, particle count as applicable) shall be verified in HVAC qualification as per requirement.Results obtained shall be compiled, reviewed and a room qualification report shall be generated.

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• Sterilization process validation• Product solution filtration validation• Media fill• Container closure integrity test• Hold study for sterilized articles• Transfer of sterilized articles• Disinfection validation• Personnel qualification• Usage of pass box in aseptic area

VALIDATIONS TO DEMONSTRATE

STERILITY ASSURANCE

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APPROACH FOR PROCESS VALIDATION

• Process validation plan• Prospective approach• Process risk analysis• Identification of GMP critical process steps & parameter• Process monitoring plan• Sampling and testing plan• Manufacturing process at the extreme ranges and data collection• Evaluation of test results and Acceptance criteria• Change control and revalidation

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APPROACH FOR CLEANING VALIDATION

• Cleaning validation project plan• Equipment and product grouping• Calculation of acceptance criteria • Establishment of cleaning method• Sampling and testing• Data collection• Review method and conclusion• Change control and revalidation

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In what Situation Requalification shall be performed

• Revalidation project plan• SOP – Change control • Revalidation/re-qualification protocols• Risk Assessment• Scheduled / Un scheduled validation

Equipment / Instruments• Substitution of existing equipment with a new equipment / instrument.• Change of site /location of the equipment / instrument.• Any major modification in the existing equipment / line since purchase

which can have an adverse effect on the quality and efficacy of the finished product.

• After rectification of major breakdown (as applicable).

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LogoAPPROACH FOR REVALIDATION/ REQUALIFICATION

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In What Situation Revalidation Shall be Performed

Manufacturing process• Change in master formula or manufacturing process• Change in Raw Materials or its Vendor• Change in type of equipment used• Change in Batch Size• Change in manufacturing site or location.

Cleaning• Change in cleaning cycles and durations• Change in cleaning agent• Change in cleaning parameters• Change in type of equipment

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• Risk Analysis – IQ/OQ/PQ/PV

• User Requirement Specification – IQ/OQ/PQ

• Process Development data – Process Validation, cleaning validation

• Official standards – Analytical Method Validation

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LogoHOW ARE THE ACCEPTANCE CRITERIA DERIVED

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• Change control system

• Training

• Operation and cleaning SOPs

• Preventative maintenance program

• Calibration program

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LogoMAJOR QUALITY SYSTEMS TO MAINTAIN THE FACILITY IN THE STATE OF VALIDATION

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The quality system typically applies to and interacts with all activities pertinent to the quality of a product. It involves all phases from initial identification to final satisfaction of requirements and customer expectations starting from marketing and market research, design/ specifications, engineering and product development, procurement, process planning and development, production, inspection, testing, examination, packing and storage, sales and distribution, installation and operation of the machine, technical assistance and maintenance.


_ Palash Chandra DasQUALITY SYSTEMS CONCEPT

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QUALITY SYSTEMS CONCEPT

Periodic self inspection/internal audit are conducted as per defined planner by a team, comprising of cross-functional departments or external auditor to review and ensure effective implementation of quality system and cGMP compliance.

Self inspection and internal audits finding are recorded and corrective measure are taken for compliance. Records of self inspection and audit are maintained

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QUALITY SYSTEMS CONCEPT RELEASE PROCEDURE FOR FINISHED PRODUCT : Manufacturing activity is carried out under the supervision of

approved manufacturing chemist after the completion of labeling and packing operation; finished goods are transferred to finished goods under test/ Quarantine area and batch record duly reviewed by approved manufacturing chemist are sent to QA for review. On completion of testing under supervision of approved analytical chemist, the Certificate of Analysis is sent to QA for review. On satisfactory compliance with both finished product specifications and batch integrity requirements, the QA department will issue a batch release note duly approved by head QA or his designee. In case a finished product fails a particular test or does not comply with the specification then a complete investigation is initiated by QC and closed by head QA after complete root cause analysis and necessary corrective and preventive action

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QUALITY SYSTEMS CONCEPT PRODUCT QUALITY REVIEWS

Immacule life sciences prepare the reviews report of product quality annually as Annual Product Review. The annual product review shall be performed as per the approved procedure to:

Confirm the validated status of product and associated manufacturing processes Identify and implement product and production process improvement. Product review shall include trending of critical process parameters during production of batches, trend analysis of product attributes, trending of stability tests results and examination of retention samples, yield of product

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QUALITY SYSTEMS CONCEPT STANDARD TESTING SPECIFICATIONS AND STANDARD TESTING

PROCEDURES

Specifications & Testing procedures are prepared in compliance with relevant pharmacopeia and are reviewed to meet current pharmacopeia recruitments.

STANDARD OPERATING PROCEDURE

Standard Operating Procedures (SOPs) are established to specify procedures, method and systems for all activities related to the development, manufacturing, storage and distribution of marketed products. SOPs contain relevant information about the documents and procedures to be followed such as cleaning, operation, calibration, validation, maintenance, training and documentation etc. to be performed.

BATCH PRODUCTION RECORDBatch Production Records are documents in accordance with prescribed specifications and provide means for ensuring that the product is manufactured under controlled and orderly conditions

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QUALITY SYSTEMS CONCEPT DEVIATION

Any deviation to the established procedure or process are reported to the quality assurance department and are thoroughly investigated for any impact on quality, deviation investigation and any supporting activities/action are documented as per Deviation Management SOP.

CHANGE CONTROLAny proposed change to a process, facility, material or equipment is reviewed by a change control committee, comprising Quality, Production and Senior Management, the decision and supporting activities/actions are documented as per Change Control SOP.

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QUALITY SYSTEMS CONCEPT RESPONSIBILITY OF WAREHOUSE

Proper placement of raw materials and packing materials so as to maintain the identity and avoid cross contamination.

Storage of raw materials and packing materials as per the specified storage condition.

Dispensing of raw materials on a FEFO (First Expiry First Out) basis and packing materials on a FIFO (First in First Out) basis.

To ensure that only the APPROVED materials are issued for Production.

To dispatch only the batches approved & released by the Quality Assurance.

To maintain the appropriate storage conditions for the Finished Goods.

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QUALITY SYSTEMS CONCEPTRESPONSIBILITY OF PRODUCTION

To manufacture sterile injectable finished doses products by aseptic process and terminally sterilized finished products.

To ensure the cleanliness of the manufacturing area, equipments before start of the manufacturing activity.

To verify the quantity of the dispensed raw materials against the batch records/ bill of material

Control of Labeling and packaging materials and reconciliation of materials. To be part of validation team for qualification and validation of processes and

process equipments. To ensure that the manufacturing of the product is done in accordance to the

instructions provided and to fill the relevant details in the batch records. Documentation of production relevant activities as per cGMP & Good

Documentation Practices (GDP). On job training Coordination with cross functional department

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RESPONSIBILITY OF ENGINEERING Preparation and execution of Preventive Maintenance Program for

equipments/instruments and utilities. Calibration of instruments. Overall maintenance of Building, equipments and machinery. Operation and maintenance of utilities.

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RESPONSIBILITY OF QUALITY ASSURANCE DEPARTMENT

Execution and approval Qualification and validation activity to ensure consistency of results.

Vendor Qualifications Self/ Internal Audits Handling of market complaints Implementation of GMP To verify manufacturing operations in compliance to established

procedure.

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RESPONSIBILITY OF QUALITY CONTROL Sampling and testing of raw materials, intermediates, finished

products and validation sample in accordance with standard procedures.

Preparation of COA after analysis. Periodical inspection of raw materials and finished products in

storage areas Maintaining reserve samples of every batch of product Performing analytical method validation Performing periodic validation activities Microbiological and Sterility Testing Analysis of water and environmental monitoring. Stability study

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Thanks for your attention !

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pharmaceutical company facility presentation

Health & Medicine