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A WHO Guide

A WHO Guide

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A WHO guide to goodmanufacturing practice(GMP) requirements
Part 2: Validation
Written by:
Gillian Chaloner-Larsson, Ph.D,GCL Bioconsult, OttawaRoger Anderson, Ph.D, Director of Quality Operations, Massachusetts Public Health Biologic LabsAnik Egan, BSc.,GCL Bioconsult, Ottawa
 In collaboration with:
Manoel Antonio da Fonseca Costa Filho, M.Sc., Consultant in Quality Assurance, Biomanguinhos/ FIOCRUZ, BrazilDr Jorge F. Gomez Herrera, Director of Quality Assurance, Gerencia General de Biologicos y Reactivos,Secretaria De Salud, Mexico
WHO/VSQ/97.02ENGLISH ONLYDISTR.: LIMITED
World Health OrganizationGeneva1997 
GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION
VACCINE SUPPLY AND QUALITY
GLOBAL TRAINING NETWORK
 
2Good manufacturing requirements -- Part 2: Validation
Printed: January 1997 
© World Health Organization 1997This document is not issued to the general public, and all rights are reserved by the World HealthOrganization (WHO). The document may not be reviewed, abstracted, quoted, reproduced ortranslated, in part or in whole, without the prior written permission of WHO. No part of thisdocument may be stored in a retrieval system or transmitted in any form or by any means –electronic, mechanical or other – without the prior written permission of WHO.
The Vaccine Supply and Quality Unit of the Global Programme for Vaccines andImmunizationthanks the following donors whose financial support has made the production of this document possible: the World Bank, USAID, JICA, the Rockefeller Founda-tion and the Governments of Australia, China, Republic of Korea, Denmark, Ire-land, Japan, Netherlands, Norway, Sweden, and the United Kingdom of Great Britainand Northern Ireland.
Copies may be requested from:
World Health OrganizationGlobal Programme for Vaccines and ImmunizationCH-1211 Geneva 27, Switzerland
Telephone:
+22 791 4373/4421
Fax:
+22 791 4193/4192
E-mail:
gpv@who.ch
The
Global Training Network 
is designed for staff of National Control Au-thorities and selected vaccine manufacturers meeting specific entrancecriteria. This document is designed for use by participants in the GlobalTraining Network, specifically for those participating in curricula re-lated to Good Manufacturing Practices.Curricula and curricula material for the Global Training Network havebeen overseen by Expert Review Panels convened at the request of WHOand comprised of experts internationally known for their profi-ciency in the particular field. The Vaccine Supply and Quality Unit wouldlike to particularly thank the experts who reviewed this document andserved on the Expert Review Panel: Dr Ian Sykes, Pharmaceutical Con-sultancy Service, Haastrecht, Netherlands, Dr Chung K Lee, Salk In-stitute, Swiftwater, Pennsylvania, USA, and Ms Carolyn Woodruff,Therapeutic Goods Administration, Melbourne, Victoria, Australia. TheGlobal Training Network is financed in part through funds donated bythe World Bank.
 
3WHO/VSQ/97.02
Contents
 Abbreviations........................................................................................................v
1. Introduction and purpose of the guide...........................................................12. Good manufacturing practices (GMP)............................................................23. Validation...........................................................................................................34. Protocols............................................................................................................45. Master validation plan.......................................................................................56. Change control..................................................................................................67. Facility systems and equipment.......................................................................78. Format for an installation qualification protocol............................................99. Format for an operational qualification protocol.........................................1410. Format for a performance qualification protocol.......................................2411. Systems and equipment: examples of IQ, OQ, and PQ protocols..........3212. Process validation..........................................................................................5313. Format for a process validation protocol....................................................5514. Typical content requirements for process validations................................6315. Validation of analytical assays......................................................................6516. Format for an analytical assay validation protocol.....................................7017. Other types of validation data......................................................................76Appendix 1: Document requirements...............................................................79Appendix 2: List of validation titles from three vaccine manufacturers..........83Appendix 3: List of reference articles and publications....................................86Appendix 4: Glossary.........................................................................................90Appendix 5: Validation protocols contributed by a vaccine manufacturer....96

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