Validation

Overview

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Purpose of Validation

•“Establish documented evidence which provides a high

degree of assurance that a specific process will consistently
produce a product meeting its predetermined specifications
and quality attributes.”
-FDA
Guideline on General Principals of Process Validation

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Validation in Real Terms
 Validation provides an approach to prove quality,
functionality and performance of a
pharmaceutical/biotechnological manufacturing
process.
 This approach can be applied to individual pieces of
equipment as well as the manufacturing process as
a whole
 Guidelines for validation are set by the FDA, but the
specifics of validation are determined by the
pharmaceutical/biotech company.

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Process vs. Equipment Validation

 Equipment can very often be looked at as a

process for the purpose of validation.
 At the very least, equipment is part of a larger
process.
 The overall delineation of a company’s
approach to the validation of its process and
equipment is laid out in the Validation Plan.

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Validation Plan

 A high level document that shows how the

organization accounts for:

 Validation Phases
 Validation Protocols
 Appropriate Validation Equipment
 Specified Validation Studies

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Validation in CGMP
 Validation has to be planned and carried out in an organized
manner. Typical steps often consist of:

 Validation Specification Development

 Design Specification
 Functional Specification
 User Requirement Specification
 Validation Protocols
 Validation Phases (GAMP V)
 DQ- Design Qualification
 IQ- Installation Qualification
 OQ-Operational Qualification
 PQ- Performance Qualification

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Validation Protocol
 Appropriate Validation Equipment
 Specified Validation Studies

What is a Validation Protocol?

 A Validation Protocol is an approved document

which outlines the program to be employed, the

tests that will be made and the acceptance criteria
for those tests.

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Validation Phases
 DQ is intended to ensure the proper equipment is
purchased to meet the user requirements.
 IQ and OQ are intended to prove that the equipment
is installed and operates per the manufacturer’s
specification.
 PQ is intended to prove that the equipment operates
according to the user’s requirements in its normal
operating environment.

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Design Qualification

 Lists requirements of equipment / system.

 Requirements are best created before
“shopping” is undertaken.
 Requirements are created by the needs of
the system/process of which the
equipment/system will be a part.

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Installation Qualification
 Description of equipment/system including physical
characteristics and function of key components.
 List of manufacturer’s specifications, drawings and
operating manuals.
 Verifying proper installation of utilities; water, steam,
electrical, compressed air, ventilation, etc.
 Calibration records for all instrumentation.

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Operational Qualification

 Verifies correct operation of critical

components and operating ranges as defined
by the specification and required
performance.
 Control System, Instruments, Mechanical Features
 Operational Tests
 Empty Chamber Mapping
 Component Operation

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Performance Qualification

 Tests to demonstrate that the

equipment/system performs in an actual as-
used scenario.
 Distribution Studies
 Container Mapping
 Heat Penetration Studies
 Microbiological Challenge Studies

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