Transcript MANUFACTURING TECHNICAL AGREEMENT BETWEEN …

EQUIPMENT
VALIDATION
This V-Model figure shows how links the URS, Functional Specification, Design
Qualification and the Testing Qualifications (IQ, OQ, PQ) :
User Requirement
Specification
Performance
Qualification
Functional
Specification
Operational
Qualification
Design
Qualification
Installation
Qualification
Installation
Flow chart
RESPONSIBILITIES
Validation team shall comprise of 4 sections as mentioned below.
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Validation core committee
Head of QA
Head of Production
Head of Engineering
Head of Quality Control
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Validation task force leader
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QA in-charge
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Validation coordinator
 Representatives from QA
Execution team
 Representative from QA
 Representative from Engineering,
 Representative from Production
 Representative from Quality Control
wherever applicable
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
Specification
User shall prepare the URS as per the requirements and it shall be
approved by Authorized personnel.
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This document shall describe all essential requirements as
described below
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Equipment / System Requirement
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Operational Requirements
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GMP Requirements
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Safety Requirements
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Documentation Requirements
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Reference and final approval of document.
The URS links to PQ phase, where in all the requirements adherence is
verified.
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:
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Detail design specifications for each of the components in equipment.
Description of functions and acceptance criteria
GMP requirements, which should be complied by equipment / system
List of Related documents required to be provided by the vendor
The Data Sheet links to OQ phase, wherein all the functions specified are
being tested.
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.
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Major components design specification includes MOC for critical components
Process control instruments/ devices specifications
Description of safety features including alarms / interlocks.
Required utilities with specifications
System / equipment engineering drawings (Mechanical / electrical).
Piping and instrumentation diagrams (P&ID).
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.
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Factory Acceptance Test (FAT) shall be performed by vendor in presence of
Engineering/user department personal at the factory before shipment of the
equipment
wherever appropriate.
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Site Acceptance Test (SAT) shall be performed by vendor in presence of Engineering/
user department personal at the site before installation of the equipment wherever
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
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.
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.
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.
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.
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.
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:
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Describe the specific tests to be conducted and rationale for testing.
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Test procedure includes sampling plan and acceptance criteria.
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A list of all test instruments used in execution of the PQ with calibration
status.
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Test data sheets to document all testing and test results.