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WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Thirty-second Report Cored Geneva 1992 Sf os NES) re i WHO Livary Cataloguing in Pubcon Osta WHO Esper Goris on Speciations fo PhrmarsucalPrepaatons WHO exper Commitee on Speeicatons fr Phamacouical Prepaatens: thty-secon ‘pot (WHO tecnica epson; 829) ‘Owug industry 2 Drugs ~ stands & Quay contol 1 Sori IgBN g2 1208286 (NLM Clsieaton: OV 773) ISSN ob. a0bs ‘ne Wore Heath Organcaionwetamesroqusts fo: parmisson to reproduce ot tanto [a publeatona in pata nfl Applications and-enaues should be akdresnes tote Ore ef Pubteatons, Nora Heath Orgarzator, Geneva, Swern, wich wl bo das te pride te aust formation on changes rade the tor lane fr new edna, ‘ed teoene ana tanaatons sendy aise (© World Health Organization 1902 Publeatons ote wons Heath rganzaon ary copyiaht protection in aocorsnce wit ‘he provsions a Prtecal 2a he Lnvertal Copyright Conventon. lights reserve, ‘Te designations employed and the pncenttion of he maton! this pletion do nat ry te expression ofan onion wnsoever on be pata he Sesto the Wes Health Organiration coneraing th aga sas olay cous troy eyo rea or ‘authors, of conceming tse delta os rors or bounds “Te mention of specif comparis cr of cern marulactures' products doesnot py {hat thay a ondoeed of commended byte Word Heath Orcalzan in petarence © ‘thors of smiar nature tha are et manvonedEvovs mod omens scope ames of propre products we dtingushed by real ates Printed in Switzerland Contents 1. Introduction 1 2 Good practices in the manufacture of pharmaceutical products, 2 2 Guidelines on inspection of pharmaceutical manufacturers 2 4 The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce 2 5, Quality assurance of pharmaceutical and biological products manufactured by recombinant DNA technology 4 «8 The intermational pharmacopoeia and related activities 4 151 Quality specifications for drug substances and dosage forms 4 82 Validation of analytical procedures 4 43 Simple test methodology 5 64 National laboretories for drug surveillance and control 5 155 Quality control of products derived from medicinal plants 5 7. Intemational Chemical Feference Substances and International Infrared Reference Spectra 6 71 Establishment of reference substances 6 172 Infrared reference spectra 7 « Stability of dosage forms 7 2. Extemporaneous preparations 8 81 Topical dosage forms 8 22 The local smal-scale preparation of ophthalmic (eye) drops 8 10. Taining of regulators 9 11, Arrangements for independent analysis of drug samples 9 ‘Acknowiedgements 10 Roferonces 12 Annex! ‘Good manufacturing practices for pharmaceutical products 14 Annex 2 Provisional guidelines on the inspection of pharmaceutical manufacturers 0 Annex 3 Proposed guidelines for implementation of the WHO Certification Scheme fon the Quality of Pharmaceutical Praducts Moving in international Commerce 92 ‘Annex 4 Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology 105 Ww

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