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Table of Contents

Preparation, Review and Approval of Equipment, Utilities Qualification document

1.0 OBJECTIVE

1.1 To lay down the procedure for the preparation, review and approval of Equipment, Utilities qualification document

2.0 SCOPE

2.1 This procedure is applicable to all qualification related to testing, manufacturing, packaging and distribution of drug products of Abc pharma Limited

3.0 RESPONSIBILITY

3.1 Validation team shall prepare and execute the qualification document.

3.2 Quality Assurance, Maintenance and functional department head or designee shall review and approval of the document.

3.3 Head Quality Assurance shall be responsible for the implementation / compliance of this SOP.

4.0 DEFINITION

4.1 Qualification: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended.

4.2 Design qualification (DQ): The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.

4.3 Installation qualification (IQ): The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and manufacturer’s recommendations.

4.4 Operational qualification (OQ): The documented verification that the facilities, system and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.

4.5 Performance qualification (PQ): The documented verification that the facilities, system and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.

5.0 PROCEDURE

5.1 All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification.

5.2 After successful completion of qualification exercise, the Equipment / instrument / Utilities shall be certified for its intended use.

5.3 Qualification activities include,

5.3.1 Design Qualification (DQ)

5.3.2 Factory Acceptance Test (FAT)

5.3.3 Site Acceptance Test (SAT)

5.3.4 Installation Qualification (IQ)

5.3.5 Operational Qualification (OQ)

5.3.6 Performance Qualification (PQ)

5.3.7 Re-qualification

Note: For standard make/ model equipments and those that are exactly similar, earlier approved protocol reference is taken and report is printed in which data is captured. Such protocols with single approval page shall bear the earlier protocol reference number, which is approved by Quality Assurance.

5.4 User requirement specification (URS)

5.4.1 A User requirement specification specifies the basic requirements for the individual aspects of facility, item of equipment, utility and systems in terms of function, capacity, output, operating parameters, control system and other cGMP/ GLP requirements. A detailed user requirement specification shall not be prepared for commercially available equipment/ instrument/system.

5.4.2 User requirement specification shall be prepared by the Maintenance dept or user department and shall be reviewed by head of designee and approved by Head Quality Assurance.

5.4.3 User shall forward the URS to purchase department to initiate the procurement.

5.4.4 Purchase shall discuss the detailed URS with respective vendors and based on the technical discussion, the vendor shall be finalized. Once the vendor is identified, the URS acceptance shall be taken from the vendor. URS acceptance by the vendor need not be taken for the machines / equipments / instruments / analytical instruments, which are of standard make and repeated orders.

5.4.5 Purchase department shall generate purchase order and submit a copy of approved URS to Vendor / supplier for procurement / fabrications.

5.5 Design Qualification (DQ)

5.5.1 Design Qualification shall be prepared for the new projects or any modification/renovation or expansion in the existing facility and for customized equipment / system.

5.5.2 The design qualification shall consist of following:

5.5.3 Objective -This section describes about the intend of design qualification.

5.5.4 Scope- This section describes the extent to which design qualification is applicable.

5.5.5 Responsibility

5.5.6 Equipment Identification

5.5.7 Acceptance Criteria

5.5.8 System Description

5.5.9 Basis of design-This section describes the basis of design like multi purpose multi equipment facility or dedicated facility, type of dosage from / product to be manufactured, capacity / out put, Temp , % RH requirements, civil design basis, electrical design basis / loads, utilities design basis, equipment design basis requirements etc.

5.5.10 Machine Specification

5.5.11 Supporting Utilities

5.5.12 Material of Construction

5.5.13 Safety Features

5.5.14 Abbreviations

5.5.15 Supporting documents

5.5.16 Conclusion and summary

5.6 Factory Acceptance Test (FAT):

5.6.1 FAT shall be carried out to ensure that all the design criteria and process requirements as laid down in the URS / Purchase order has been addressed by the vendor.

5.6.2 Factory Acceptance Test shall be conducted at manufacturer’s/ supplier’s site by inspection team comprising of representative from User and Projects / Maintenance department.

5.6.3 Factory acceptance test shall be performed for custom-built equipment / system / instrument(s) only.

5.6.4 The inspection team shall finally give the clearance for dispatch of the Equipment / system / instrument.

5.7 Site Acceptance Test (SAT): Site Acceptance Test shall be carried out by Validation team / Maintenance / Project / User at users end to ensure that all the arrangements are made as per general arrangement GA / P&ID drawing, manufacturer’s / supplier’s recommendation, which includes identification of utilities, foundation for equipment installation and electrical arrangements.

5.8 Installation Qualification (IQ):

5.8.1 Installation Qualification shall be carried out to ensure that all aspects of the facility/utility/equipment/instrument that can affect product quality adhere to User Requirement Specification / Manufacturer’s recommendations.

5.8.2 Installation Qualification activity shall be categorized into two phases. IQ shall include general and functional verification of any utility/equipment/

5.8.3 General verification of IQ includes

5.8.3.1 Identification of execution team members: Identify the execution team members from Quality Assurance, user department and any other related departments as per the requirement.

5.8.3.2 Verification of Drawing(s), Manual(s) and related document(s): List out the drawings, manuals received.

5.8.3.3 Installation Checklist: Verify the proper installation of the equipment / system as per user requirement specification / manufacturer’s recommendation.

5.8.3.4 Verification of Material of construction: Check the material of construction of contact / non-contact parts of the equipment / system and check the manufacturer’s certificate thereof. List out and verify the contact / non –contact parts.

5.8.3.5 Verification of Utilities: Check the utilities connected to the equipment / system as per requirement and verify the same at the user point.

5.8.3.6 Major component verification: Identify and list out major components and check whether they are installed as per design specification / user requirement specification / Manufacturer’s recommendation.

5.8.4 General Verification of OQ includes,

5.8.4.1 Instrument calibration

5.8.4.2 Identify and classify the measuring instrument as critical / non critical and calibrate as per the procedure. .

5.8.4.3 Verification of procedures

5.8.4.3.1 Verify the procedure in connection with the operation of the equipment / system, preventive maintenance and record the details in General Verification format- Verification of Procedures.

Note: i) Reports of IQ/OQ & PQ bears only the important content pages like report identity page, table of content, summary and conclusion and certification pages.

ii) All other applicable common formats are attached at time of execution of the qualification document.

5.8.5 Functional Verification of OQ includes,

5.8.5.1 Control Panel Testing

5.8.5.1.1 Check the electrical /MMI or HMI/pneumatic switches function testing provided on control panel. For custom built equipments, perform the control panel testing once. Control panel testing of standard equipments shall be performed as part of verification of Operating Instructions / Standard Operating Procedures.

5.8.5.2 Safety Feature Testing

5.8.5.2.1 Check all the safety features (interlocks) in connection with the equipment / system. Repeat the exercise for two more times.

5.8.5.3 Operational Testing

5.8.5.3.1 Verify the operating parameters of the equipment /instrument / system for the efficiency of the equipment and its components.

5.8.5.4 Performance of Motor / Blower.

5.8.5.5 Check and record the other critical operating parameters in the Functional Verification and record the detail in report.

5.8.5.6 Ensure that the calibration details of standard instruments used for checking the operating parameters are within the validity and record the calibration details.

5.9 Performance Qualification (PQ):

5.9.1 Performance qualification shall be carried out for all manufacturing equipment/ laboratory instruments and supporting utilities.

5.9.2 Performance qualification shall be carried out by conducting Trial run using placebo or product.

5.9.3 Performance qualification can also be performed along with operational qualification where found appropriate and with proper justification.

5.9.4 Performance Qualification protocol shall be prepared based on the type of the equipment / test to be conducted or challenges to be performed.

5.10 The performer shall carry out all the qualification activities mentioned in the protocol and sign immediately after completion of each activity in the checked by/date column provided for the same.

5.11 The reviewer shall counter check and certify that the performer has carried out the validation activities as per the test procedure
of the protocol and sign in the Verified by/date column provided for the same.

5.12 The approved validation documents shall be handed over to Quality Assurance.

5.13 Re-qualification:

5.13.1 Re-qualification shall be triggered, if there is change in location from one area to another area, major modification in the equipment, which has a direct impact on the product quality. The same shall be captured through change control.

5.13.2 Re-qualification shall be carried out by preparing the supplementary qualification protocol based on the change control committee recommendation.

5.13.3 The Supplementary validation shall be carried out by using the related general verification and functional verification format depend upon the type of the change/modification made therein.

5.13.4 After completion of validation / qualification activity, final approval / certification shall be taken before put into operation.

5.13.5 The equipments like Dry Heat Sterilizer, Autoclave, HVAC system, LAF/RLAF workstation etc. shall be subjected to revalidation in accordance with the defined schedule.

5.13.6 If there is no changes or modification in the equipment / system, periodic assessment shall be carried out to ensure that it is in validated state. The frequency shall be once in two years.

5.13.7 Periodic assessment study shall consist of verification of details like calibration records, preventive maintenance record, history card of the equipment / system, Physical status of the equipment / system, empty run of the equipment / system. The same shall be recorded in the supplement qualification protocol.

5.13.8 In case of laboratory instruments or any other instrument / equipment, validation documents provided by the vendor, the same shall be considered as validation / qualification document.

5.14 Utility Qualification:

5.14.1 Water system

5.14.1.1 The qualification includes water generation, storage and distribution system.

5.14.1.2 Following shall be covered under water system qualification

5.14.1.3 Design Qualification :

5.14.1.3.1 Acceptance criteria

5.14.1.3.2 Basis of Design

5.14.1.3.3 System Description and technical specification

5.14.1.3.4 Critical safety features

5.14.1.3.5 Physical particulars checklist.

5.14.1.4 Installation Qualification:

5.14.1.4.1 Water system description

5.14.1.4.2 Major component verification

5.14.1.4.3 Utilities verification

5.14.1.4.4 Hydro Test

5.14.1.4.5 Verification of Supporting documents

5.14.1.5 Operational Qualification:

5.14.1.5.1 Operational testing

5.14.1.5.2 Calibration of critical Instruments

5.14.1.5.3 Drainability test repot

5.14.1.5.4 Dead leg measurement

5.14.1.5.5 Operation/Cleaning/Sanitization/Passivationprocedure.

5.14.1.6 Performance Qualification:

5.14.1.6.1 To ensure that the water systems including Raw water system, RO water System, Purified water system and WFI system, meet the In-House and Pharmacopoeial specifications of IP, BP USP.

5.14.1.6.2 To confirm the appropriateness of critical parameters of the water system.

5.14.1.6.3 To perform water drain time study.

5.14.1.6.4 To perform Hold time study for purified water & WFI in the water storage tank.

5.14.1.6.5 To establish reliability of water system.

5.14.1.6.6 To establish the efficacy of sanitization procedures.

5.14.1.6.7 To validate the system and check its performance.

5.14.2 HVAC system:

5.14.2.1 The Air handling system (AHU) catering to warehouse area, process area and quality control lab shall be considered for qualification. Following shall be covered under HVAC system qualification

5.14.2.2 Design Qualification shall cover followings:

5.14.2.2.1 Acceptance criteria

5.14.2.2.2 Design specification

5.14.2.2.3 Machine description and technical specification of all components.

5.14.2.2.4 Details of utilities

5.14.2.2.5 Material of construction of all components.

5.14.2.2.6 Safety features and alarms.

5.14.2.3 Installation Qualification shall cover followings:

5.14.2.3.1 HVAC system description

5.14.2.3.2 Major component verification

5.14.2.3.3 Utilities verification

5.14.2.3.4 Verification of supporting documents.

5.14.2.4 Operational Qualification shall cover followings:

5.14.2.4.1 Operational testing

5.14.2.4.2 Calibration of critical Instruments

5.14.2.4.3 Filter Integrity test report

5.14.2.4.4 Differential Pressure across the filter

5.14.2.4.5 Air velocity and air changes

5.14.2.4.6 HEPA filter insulation integrity

5.14.2.4.7 Verification of safety feature and interlocks

5.14.2.5 Performance Qualification shall covers followings:

5.14.2.5.1 Room Temperature and Humidity

5.14.2.5.2 Room Pressure Differential

5.14.2.5.3 Air Flow Pattern

5.14.2.5.4 Viable and Non viable Particle count

5.14.2.5.5 HEPA Filter integrity and recovery rate

5.14.2.5.6 Air Flow velocities and No. of air changes.

5.14.3 Compressed Air Qualification:

5.14.3.1 Compressed Air system shall be qualified where the compressed air directly comes in contact with the products.

5.14.3.2 Design Qualification shall covers followings:

5.14.3.2.1 Acceptance criteria

5.14.3.2.2 Basis of design

5.14.3.2.3 System Description and technical specification

5.14.3.2.4 Critical safety features.

5.14.3.2.5 Physical particular checklist.

5.14.3.3 Installation Qualification shall covers followings:

5.14.3.3.1 Compressed Air system description

5.14.3.3.2 Major component verification

5.14.3.3.3 Utilities verification

5.14.3.3.4 Verification supporting Documents.

5.14.3.4 Operational Qualification shall covers followings:

5.14.3.4.1 Operational testing

5.14.3.4.2 Calibration of critical instrument

5.14.3.4.3 Filter integrity test report

5.14.3.4.4 Verification of safety features and interlock

5.14.3.4.5 Verification of standard operating procedure and preventive maintenance.

5.14.3.5 Performance Qualification shall covers followings:

5.14.3.5.1 Airborne Particle count.

5.14.3.5.2 Moisture Content.

5.14.3.5.3 Hydrocarbons as Oil Mist.

5.14.3.5.4 Microbial load.

Note: The standard equipments / instruments like Vernier calipers, Disintegration tester, Friabilator, Hardness tester, Weighing balance, Moisture analyzer, Leak test apparatus etc shall be calibrated before putting into use.

6.0 REFERENCES

SOP on Preparation review and approval of Validation Master Plan

7.0 ABBREVATION(S)

Abbreviation	Full Description
cGMP	Current Good Manufacturing Practice
GLP	Good Laboratory Practice
URS	User Requirement Specification
FAT	Factory Acceptance Test
SAT	Site Acceptance Test
DQ	Design Qualification
IQ	Installation Qualification
OQ	Operational Qualification
PQ	Performance Qualification
HVAC	Heating, ventilation and Air Conditioning system
AHU	Air Handling Unit
SOP	Standard Operating Procedures(s)
MMI / HMI	Man Machine Interface / Human Machine interface
UPS	Uninterrupted Power Supply
HEPA	High Efficiency Particulate Air Filters
GA	General Arrangement
P&ID	Piping and Instrumentation drawing
LAF/RLAF	Laminar Air Flow / Reverse Laminar Air Flow