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:
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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
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Design Specification Functional Specification User Requirement Specification

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Validation Protocols Validation Phases (GAMP V)
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DQ- Design Qualification IQ- Installation Qualification OQ-Operational Qualification PQ- Performance Qualification

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Validation Protocol
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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
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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 Empty Chamber Mapping Component Operation

Operational Tests
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Performance Qualification

Tests to demonstrate that the equipment/system performs in an actual asused scenario.
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Distribution Studies Container Mapping Heat Penetration Studies Microbiological Challenge Studies

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