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Working document QAS/03.055/Rev.2RESTRICTED

WORLD HEALTH ORGANIZATIONORGANISATION MONDIALE DE LA SANTE

SUPPLEMENTARY GUIDELINES ONGOOD MANUFACTURING PRACTICES (GMP):VALIDATION

World Health Organization 2005

All rights reserved.This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft.The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in partor in whole, in any form or by any means outside these individuals and organizations (including the organizations’concerned staff and member organizations) without the permission of WHO. The draft should not be displayed on anywebsite.Please send any request for permission to:Dr Sabine Kopp, Quality Assurance & Safety: Medicines (QSM), Department of Medicines Policy and Standards(PSM), World Health Organization, CH-1211 Geneva 27, Switzerland.Fax: (41-22) 791 4730; e-mails:kopps@who.int; bonnyw@who.int The designations employed and the presentation of the material in this draft do not imply the expression of any opinionwhatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city orarea or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps representapproximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by the World Health Organization in preference to others of a similar nature that are not mentioned.Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.The World Health Organization does not warrant that the information contained in this draft is complete andcorrect and shall not be liable for any damages incurred as a result of its use.

This document has followed the steps given in the schedule on page 2 herein. It has been very widelydistributed and numerous comments have been incorporated.Please address any comments you may have on this revised document to Dr S. Kopp, Quality Assurance andSafety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27,Switzerland; fax: (+41 22) 791 4730 or e-mail:kopps@who.int, with a copy tobonnyw@who.int,

by 20 October 2005

Working document QAS/03.055/Rev.2page 2

SCHEDULE FOR THE ADOPTION PROCESS OF DOCUMENT QAS/03.055/Rev.2:SUPPLEMENTARY GUIDELINES ON GMP: VALIDATIONDeadline

First draft prepared and mailed for comments 20 January 2003Deadline for receipt of comments 28 February 2003Collation of comments March 2003Revision of draft document July-August 2003Mailing of draft for second round of commentsSeptember 2003Deadline for receipt of comments 15 November 2003Collation of comments December 2003Evaluation of comments March 2004Consultation to discuss comments May 2004Presentation to Thirty-ninth WHO Expert Committee onSpecifications for Pharmaceutical PreparationsOctober 2004Incorporation of comments of the meeting of May 2005 June 2005Finalization of next revised version July 2005Mailing for third round of comments September 2005Presentation to Fortieth WHO Expert Committee onSpecifications for Pharmaceutical Preparations24-28 October 2005

Working document QAS/03.055/Rev.2page 3

SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES(GMP): VALIDATIONCONTENTS

page1.

Introduction 42.

Glossary 53.

Scope of document 84.

Relationship between validation and qualification 85.

Validation 85.1. Approaches to validation 85.2. Scope of validation 96.

Qualification 107.

Calibration and verification 108.

Validation Master Plan (VMP) 109.

Qualification and Validation Protocols 1110.

Qualification and Validation Reports 1111.

Qualification stages 1212.

Change Control 1413.

Personnel 1514.

References 15Annex 1. Validation of Heating, Ventilation and Air Conditioning 16(HVAC) systemsAnnex 2. Validation of Water systems for pharmaceutical use 22Annex 3. Cleaning validation 24Annex 4. Analytical method validation 33Annex 5. Validation of computerized systems 38Annex 6. Qualification of systems and equipment 44Annex 7. Non-sterile process validation 73