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Validation

Basic Principles of GMP

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Validation

Objectives

To review the definition and types of validation

To understand the requirements for documentation and key stages in the process of validation

To consider models for process validation

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Validation

Definition

Validation is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result

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Validation

Essential Part of GMP Predetermined protocols

Written reports

Processes and procedures

Periodic revalidation

Specific attention: processing testing cleaning

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Annex 6

Validation

WHO References

Good manufacturing practices: guidelines on the validation of manufacturing processes

Validation of analytical procedures used in the examination of pharmaceutical materials

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Validation

Types of Process Validation Experimental approach

Prospective validation Concurrent validation

Analysis of historical data Retrospective validation

Revalidation Periodic revalidation Revalidation after change

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Validation

Stages of Validation

Design qualification (DQ)

Installation qualification (IQ)

Operational qualification (OQ)

Performance qualification (PQ)

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Validation

Priorities for Process Validation

Type of process Requirement

New Every new process before approval for routine Existing:

Sterile products All processes affecting the sterility, and manufacturing environment

including sterilization stage

Non-sterile Low dose tablets and capsules: mixing and granulation; content uniformity (and other parameters)

Other tablets and capsules: uniformity of mass (and other parameters)

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Validation

Types of Documentation

Validation Master Plan (VMP)

Validation protocols (VP)

Validation reports (VR)

Standard Operating Procedures (SOPs)

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Validation The Validation Master Plan could consist of:

Approval page and table of contents Introduction and objectives Facility and process description Personnel, planning and scheduling Responsibilities of committee members Process control aspects Equipment, apparatus, processes and systems to be

validated Acceptance criteria Documentation e.g.validation protocols and reports SOPs Training requirements

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Validation Protocol

Objectives of the validation and qualification study

Site of the study Responsible personnel Description of the equipment SOPs Standards Criteria for the relevant products and processes

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Validation Report

Title Objective of the study Refer to the protocol Details of material Equipment Programmes and cycles use Details of procedure and test methods

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Validation

Group Session 1: Option 1

From your experience of factory inspections, what progress has been made in introducing validation in your country?

What are the major obstacles and how can they be overcome?

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Validation

Group Session 1: Option 2

List some documents related to validation, that you expect to find at a manufacturing site.

Identify aspects in each document that you would evaluate or assess.

What problems do you anticipate the company to have faced when the company drafted these documents?

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Validation

Possible Issues Lack of time

Lack of personnel

Lack of experience and knowledge

Changes to the process

Prospective versus retrospective validation

Lack of documentation infrastructure

Lack of implementation of validation

Poorly designed documents

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Validation

WHO Model for

Validation Protocol and Report - I

Part 1 – Purpose and prerequisites

Part 2 – Presentation of the process

Part 3 – Validation protocol

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Validation

WHO Model for

Validation Protocol and Report - II

Part 4 – Installation qualification

Part 5 – Qualification protocol/report

Part 6 – Product characteristics

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Validation

WHO Model for

Validation Protocol and Report - III

Part 7 – Evaluation

Part 8 – Certification

Part 9 – Summary

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Validation

Group Session 2

List the aspects that you will evaluate when assessing the validation for the project that your group has been given.

Identify the critical parameters that should have been evaluated by the manufacturer.

List the tests to be carried out and comment on the acceptance criteria to be set.

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Validation

Possible situation – I

Refurbishment of a liquids department, producing a single product on an established site with an existing purified water system.

Ventilation system Equipment and process Training

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Validation

Possible situation – II

New product introduced into an existing tablet manufacturing site, with 20 products already being produced Process Cleaning Training

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Validation

Possible situation – III

A new liquids manufacturing building on an existing site which will produce 2 products. Ventilation Equipment and process Cleaning Training

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Validation

Possible situation– IV

An existing sterile suite producing 5 products that are terminally sterilized Sterilizers Ventilation and other environmental aspects Equipment and process Cleaning Training