2 User Requirement Specification Installation Qualification This V-Model figure shows how links the URS, Functional Specification, Design Qualification and the Testing Qualifications (IQ, OQ, PQ) :User Requirement SpecificationPerformance QualificationFunctional SpecificationOperational QualificationDesign QualificationInstallation QualificationInstallationFlow chart
3 Head of Engineering wherever applicable Head of Quality Control RESPONSIBILITIESValidation team shall comprise of 4 sections as mentioned below.Validation core committeeHead of QA Head of Production Head of Engineering wherever applicable Head of Quality Control· Validation task force leaderQA in-charge· Validation coordinatorRepresentatives from QAExecution teamRepresentative from QA Representative from Engineering, Representative from Production Representative from Quality Control
4 User Requirement Specification (URS) The URS defines the functions to be carried out, the data on which the system will operate, and the operating environment.All major equipments / systems shall have a formal User Requirement SpecificationUser shall prepare the URS as per the requirements and it shall be approved by Authorized personnel.v This document shall describe all essential requirements as described belowv Equipment / System Requirementv Operational Requirementsv GMP Requirementsv Safety Requirementsv Documentation Requirementsv Reference and final approval of document.The URS links to PQ phase, where in all the requirements adherence is verified.
5 Data Sheet (Functional Specification) Data Sheet describes the detailed functions of the equipment / system. The Data Sheet is the base for the development of design specifications and provides the acceptance criteria for the corresponding test plans and specifications.Based on URS, Data sheet (functional Specification) shall be prepared by Engineering department and forward data sheet along with indent to purchase.The Data Sheet should detail the specifications as described below:v Detail design specifications for each of the components in equipment.v Description of functions and acceptance criteriav GMP requirements, which should be complied by equipment / systemv List of Related documents required to be provided by the vendorThe Data Sheet links to OQ phase, wherein all the functions specified are being tested.v
6 Design Qualification (Design Specification) This describes the equipment or system in sufficient detail to enable it to be built. The key design specifications are identified as below:Design Qualification (Design Specification) shall be prepared by the vender in conjunction with engineering department, after finalization of vendor. Authorized personnel of both the sides shall approve DQ.v Major components design specification includes MOC for critical componentsv Process control instruments/ devices specificationsv Description of safety features including alarms / interlocks.v Required utilities with specificationsv System / equipment engineering drawings (Mechanical / electrical).v Piping and instrumentation diagrams (P&ID).v Software/PLC specifications including drawings, wiring diagrams etc.The supplier in conjunction with engineering department prepares Design Qualification.The Design Qualification links to IQ phase, wherein all the specifications stated are being verified.v Factory Acceptance Test (FAT) shall be performed by vendor in presence ofEngineering/user department personal at the factory before shipment of the equipmentwherever appropriate.v Site Acceptance Test (SAT) shall be performed by vendor in presence of Engineering/user department personal at the site before installation of the equipment whereverappropriate.
8 Installation Qualification Installation qualification is associated with the installation of the system/equipment. Its function is to verify static attributes through defined procedures and supporting documentation that all critical aspects of the system have been installed in accordance with the approved Design Qualification and manufacturer’s recommendations.The following tests shall be covered in installation Qualification. In each of the following tests the documents / parameters / systems described in the appropriate test data sheet shall be verified as per the procedure outlined therein.Identification & verification of documents –The purpose of this test is to identify & verify the availability of documents associated with the equipment/system.Identification & verification of supporting utilities –The purpose of this test is to identify & verify that all the utilities required for installation & operation of the equipment/system have been provided as per specifications in P&ID / manual.
9 Installation Qualification Verification of equipment as per the drawings –To verify that the piping & electrical wiring has been done as per the wiring diagrams and that the equipment/ system has been installed as per the drawings provided in the installation manual. Identification & verification of Instruments –The purpose of this test is to identify and verify the major process monitoring / control instruments present in the equipment/ system.Identification of safety & interlock system –The purpose of this test is to identify & verify all the safety & interlock features present with the Equipment/ system.Identification of standard operating procedures –The purpose of this test is to identify the relevant SOP’s for the equipment.
10 Installation Qualification Verification of major components & accessories – The purpose of this test is to verify that the major components & accessories of the Equipment/ system are present & that no physical damage has occurred to the same. Verification of specifications of major components – The purpose of this test is to verify that the major component / accessory is as per the specifications. Verification of material of construction – The purpose of this test is to verify the ‘material of construction’ of major components & accessories present in the Equipment/system is as per the specifications. Verification of equipment installation – The purpose of this test is to verify that equipment/ system (including sub-components & accessories) is properly installed as per the manufacturers specifications / system requirements.
11 Operational Qualification Operational qualification function is to verify the equipment operation with functional testing through out all anticipated operating ranges. The operational tests will be designed to demonstrate the equipment’s ability to operate in accordance with approved functional specifications.The following tests shall be covered in installation Qualification. In each of the following tests the parameters / functional keys described in the appropriate test data sheet shall be verified as per the procedure outlined therein.Calibration of Process control instruments –Is to verify the calibration status of the process control instruments that are required for the effective operation of the equipment.Verification of functional keys –Is to identify the presence of all the functional keys in the equipment & that they performs the intended action when activated / operated.
12 Operational Qualification Verification of design parameters of the equipment –Is to verify that the equipment supplied is as per the standard / design parameters.Verification of standard operating procedures –Is to verify all the relevant SOP’s for their accuracy.Verification of sequential operation of the equipment [simulation cycles] –Is to demonstrate that the equipment / system is capable of achieving the desired results reproducibly when operated as per the set parameters.Verification of effect of power failure on the equipment –Is to ensure that the system reverts to fail-safe condition in event of power failure, and that it returns to the specified state when power is restored and can be restarted.
13 Performance Qualification The function of Performance qualification is to verify through testing whether the system / equipment can operate the process as specified in the User Requirement Specification under normal and boundary conditions.This PQ protocol generally includes the following:Describe the specific tests to be conducted and rationale for testing.Test procedure includes sampling plan and acceptance criteria.A list of all test instruments used in execution of the PQ with calibration status.Test data sheets to document all testing and test results.
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