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WHO/VSQ/97.01 ENGLISH ONLY DISTR.: LIMITED

A WHO guide to good manufacturing practice (GMP) requirements
Part 1: Standard operating procedures and master formulae
Written by: Gillian Chaloner-Larsson, Ph.D, GCL Bioconsult, Ottawa Roger Anderson, Ph.D, Director of Quality Operations, Massachusetts Public Health Biologic Labs Anik Egan, BSc.,GCL Bioconsult, Ottawa In collaborationwith: Manoel Antonio da Fonseca Costa Filho, M.Sc., Consultant in Quality Assurance, Biomanguinhos/ FIOCRUZ, Brazil Dr Jorge F. Gomez Herrera, Director of Quality Assurance, Gerencia General de Biologicos y Reactivos, Secretaria De Salud, Mexico

GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION

VACCINE SUPPLY AND QUALITY
GLOBAL TRAINING NETWORK World Health Organization Geneva 1997

TheGlobal Training Network is designed for staff of National Control Authorities and selected vaccine manufacturers meeting specific entrance criteria. This document is designed for use by participants in the Global Training Network, specifically for those participating in curricula related to Good Manufacturing Practices. Curricula and curricula material for the Global Training Network havebeen overseen by Expert Review Panels convened at the request of WHO and comprised of experts internationally known for their proficiency in the particular field. The Vaccine Supply and Quality Unit would like to particularly thank the experts who reviewed this document and served on the Expert Review Panel: Dr Ian Sykes, Pharmaceutical Consultancy Service, Haastrecht, Netherlands, DrChung K Lee, Salk Institute, Swiftwater, Pennsylvania, USA, and Ms Carolyn Woodruff, Therapeutic Goods Administration, Melbourne, Victoria, Australia. The Global Training Network is financed in part through funds donated by the World Bank.

The Vaccine Supply and Quality Unit of the Global Programme for Vaccines and Immunization thanks the following donors whose financial support has madethe production of this document possible: the World Bank, USAID, JICA, the Rockefeller Foundation and the Governments of Australia, China, Republic of Korea, Denmark, Ireland, Japan, Netherlands, Norway, Sweden, and the United Kingdom of Great Britain and Northern Ireland.

Copies may be requested from: World Health Organization Global Programme for Vaccines and Immunization CH-1211Geneva 27, Switzerland Telephone: +22 791 4373/4421 • Fax: +22 791 4193/4192 • E-mail: gpv@who.ch

Printed: January 1997

© World Health Organization 1997 This document is not issued to the general public, and all rights are reserved by the World Health Organization (WHO). The document may not be reviewed, abstracted, quoted, reproduced or translated, in part or in whole, without the priorwritten permission of WHO. No part of this document 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 views expressed in documents by named authors are solely the responsibility of those authors.

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Good manufacturing requirements -- Part 1: SOPs and master formulaeContents

Abbreviations ....................................................................................................... iv 1. Introductionand purpose of the guide ............................................................ 1 2. Good manufacturing practices (GMP) ........................................................... 2 3. Quality management........................................................................................ 3 4. Documentation ................................................................................................. 5
4.1. Standard operating procedures, specifications and master formulae .... 5 4.2 Forms for recording data ............................................................................... 5 4.3 Identification numbers...