Good manufacturing practices: guidelines on validation

Background:

The need for revision of the published World Health Organization (WHO) Supplementary guidelines on good manufacturing practices: validation (1) was identified by the Prequalification of Medicines Programme and a first draft document was circulated for comment in early 2013. The focus, at that time, was revision of the appendix on Non-sterile process validation (Appendix 7) (2), which had been revised and was adopted by the ECSPP at its Forty-ninth meeting in October 2014 (3).

The overarching text presented in this annex constitutes the general principles of the new guidance on validation.

The following appendices included in this annex address specific aspects of validation and are intended to complement the general text on validation:

■ Appendix 1. Validation of heating, ventilation and air-conditioning systems (as cross-reference to TRS 1010, Annex 8 (4))

■ Appendix 2. Validation of water systems for pharmaceutical use (as published in TRS 937, Annex 4, 2006 and as cross-reference to TRS 970, Annex 2, 2012 (5)

■ Appendix 3. Cleaning validation (as published in TRS and TRS 937, Annex 4, 2006 and as cross-reference to TRS 970, Annex 2, 2012 (5)

■ Appendix 4. Analytical procedure validation (adopted, subject to a review of the comments received by a subgroup of the Expert Committee)

■ Appendix 5. Validation of computerized systems (adopted, subject to the changes discussed by the Expert Committee)

■ Appendix 6. Guidelines on qualification (adopted, subject to a review of the comments received by a subgroup of the Expert Committee)

■ Appendix 7. Non-sterile process validation (as published in TRS 992, Annex 3, 2015 (3)).

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Table of Contents

1. Introduction

2. Scope

3. Glossary

4. Relationship between validation and qualification

5. Validation