Pharmaceutical Company Facility Presentation

MAKE YOU COMPANY PRESENTATION
DURING AUDIT
Presented By :
Palash Chandra Das.
www.uscgmp.com (official blog)
Applicable for Sterile
Pharmaceuticals

<PASTE ONE SIMPLE PHOTOGRAPHS OF YOUR
COMPANY>
 WELCOME TO
 XYZ Pharmaceuticals
<Add tag line if any>
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ABOUT US
<Write brief description of your organization>
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OUR TEAM
Give core team details
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Logontowww.uscgmp.com_Palash
ChandraDas

ORGANOGRAM MD
Technical Director
Plant Head
Head Engg.Head Production Head HR Head
Acc./Finance
Head QAHead 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 Functions
Quality Assurance
Quality Control
Warehouse
Engineering
EHS
HR & Administrations
Finance
Purchase
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SITE PLAN
SECTION AREA Sq.m
TOTAL LAND
BLOCK X
BLOCK Y
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Add Site Master Plan

GROUND FLOOR (PRODUCTION)
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GROUND FLOOR (WAREHOUSE)
Add Other related layout
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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 Machine
Vial Filling & Stoppering Machine
Lyophilizer (with automatic loading and unloading system)
Vial Sealing Machine
Process Sterilizer
Terminal Sterilizer
Auto Inspection M/c ( Ampoule / Vial )
Combi Labelling M/c ( Ampoule / Vial )
Blister Packing M/c
Auto Cartonator
Colwrap Machine
MANUFACTURING Paste
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ENGINEERING 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
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KEY FEATURES OF PSG SYSTEM
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HVAC SYSTEM SCHEMATIC
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KEY FEATURES OF HVAC SYSTEM
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KEY FEATURES OF BMS
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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 CONTROL
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QUALITY CONTROL
INSTRUMENTATIONS
SR.N
O
INSTRUMENT NAME MAKE
1 High Performance Liquid Chromatograph Shimadzu
2 Gas Chromatography along with Head Space
Analyzer (GC, Head space GC)
Agilent Tech
3 TOC Analyzer with auto sampler Shimadzu
4 FTIR with ATR technology Agilent Tech
5 UV- Visible Spectrophotometer Agilent Tech
6 Auto / KF -Titrator Metrohm
7 Polari meter Rudolph
8 Analytical Balance Mettler
9 pH Meter & Conductivity Meter Mettler
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QUALITY POLICY
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QUALIFICATION
&
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 Approach
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Quality Risk
Management
Qualification
Process
Flow
Direct
Impact
Systems
User
Requirement
specification
GMP Risk
Analysis
Impact
Assessment
Does system
directly impact
product quality?
Yes
Design
Qualification
Installation
Qualification
Operational
Qualification
Performance
Qualification
NO
Does system
support direct
impact System?
Yes
Reduced
Qualification
IQ & OQ or IOQ
Indirect
Impact
Systems
NO
No
Impact
Systems
Qualification
Complete
User
Compliance
Document
Vendor Sheet
commissioning
report
START
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VALIDATION PLANNING
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IMPACT ASSESSMENT (Specimen)
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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
equipment
The 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
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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 processes
Risk Review
RISK MANAGEMENT PROCESS (ICH Q9)
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RISK ANALYSIS (SPECIMEN) Paste
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USER REQUIREMENT SPECIFICATION
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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 the
Protocol
Describe the equipment
Define Responsibilities
Functional specification
Verify compliance with
User requirement
Specification and RA
YES
Prepare and approve
DQ summary report
IDENTIFICATION VERIFICATION
Comply Requirement
NO
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 the
vendor. 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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(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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(BASED ON USP)
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IMPACT ASSESSMENT (SPECIMEN)
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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.
PERFORMANCE QUALIFICATION
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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 Features
Room 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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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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HOW 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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MAJOR 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.
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QUALITY SYSTEMS CONCEPT
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 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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 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
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 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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 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 RECORD
Batch 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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 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 CONTROL
Any 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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 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
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RESPONSIBILITY 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 61
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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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ChandraDas
Thanks for your attention !
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