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QA Pharmaceutical

QA Pharmaceutical

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Published by: alhalili on Aug 29, 2009
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Quality assurance ofpharmaceuticals
A compendium of guidelinesand related materials
Volume 2, 2nd updated edition 
Good manufacturing practicesand inspection
 
WHO Library Cataloguing-in-Publication DataQuality assurance of pharmaceuticals : a compendium of guidelines and related materials.Vol. 2, Good manufacturing practices and inspection. – 2
nd
ed.1.Drug and narcotic control – standards2.Drug industry – standards3.Pharmaceutical preparations – standards4.Biological products – standards5.Quality control6.GuidelinesI.World Health OrganizationII.Title: Good manufacturing practices and inspectionISBN 92 4 154708 1(NLM classication: QV 33)ISBN 978 92 4 154708 6
 ©World Health Organization 2007
All rights reserved. Publications of the World Health Organization can be obtained fromWHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland(tel.:
+
41 22 791 3264; fax:
+
41 22 791 4857; e-mail: bookorders@who.int). Requests forpermission to reproduce or translate WHO publications – whether for sale or for noncom-mercial distribution – should be addressed to WHO Press, at the above address (fax:
+
4122 791 4806; e-mail: permissions@who.int).The designations employed and the presentation of the material in this publication do notimply the expression of any opinion whatsoever on the part of the World Health Organiza-tion concerning the legal status of any country, territory, city or area or of its authorities, orconcerning 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 implythat they are endorsed or recommended by the World Health Organization in preference toothers of a similar nature that are not mentioned. Errors and omissions excepted, the namesof proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by the World Health Organization to verify theinformation contained in this publication. However, the published material is being dis-tributed without warranty of any kind, either expressed or implied. The responsibility for theinterpretation and use of the material lies with the reader. In no event shall the World HealthOrganization be liable for damages arising from its use.Printed in India
 
Contents
iii
Introduction
1
1.WHO good manufacturing practices: main principles forpharmaceutical products
7
Quality management in the drug industry: philosophy andessential elements (update on sampling)
(new)
7Heating Ventilation and air-conditioning systems for non-sterilepharmaceutical dosage forms
(new)
58Validation
(new)
101Water for pharmaceutical use
(new)
170
2.WHO good manufacturing practices: starting materials
188Active pharmaceutical ingredients (bulk drug substances)188Pharmaceutical excipients196
3.WHO good manufacturing practices: specificpharmaceutical products
215Sterile pharmaceutical products215Biological products232Investigational pharmaceutical products for clinical trialsin humans242The manufacture of herbal medicines
(updated)
254Radiopharmaceutical products276
4.Inspection
285Pre-approval inspections285Inspection of pharmaceutical manufacturers291Inspection of drug distribution channels303Quality systems requirements for national goodmanufacturing practice inspectorates322Guidance on good manufacturing practices:inspection report338Model certicate of good manufacturing practices347

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