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Thirty-sixth report

Author: WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Publisher: Geneva : World Health Organization, 2002.
Series: Technical report series (World Health Organization), 902.
Edition/Format:   Print book : International government publication : EnglishView all editions and formats
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Material Type: Government publication, International government publication, Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: WHO Expert Committee on Specifications for Pharmaceutical Preparations.
ISBN: 924120902X 9789241209021
OCLC Number: 50118008
Notes: "WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 31 May to 4 June 1999"--Page v.
Description: vii, 208 pages : illustrations ; 24 cm.
Contents: Qality control: specifications and tests. The International pharmacopoeia: 50 years on. Monographs for The International pharmacopoeia. Dissolution test requirements for individual monographs. Basic tests for phamaceutical substances and dosage forms --
Quality control: reference materials. International chemical reference substances. International infrared reference spectra. Biological reference materials. Information on reference materials for pharmacopoeial analysis --
Quality control: pharmaceutical control laboratories. Good practices for national pharmaceutical control laboratories. Equipment for drug control laboratories. Requests for analysis of drug samles. External quality assessment --
Quality assurance: good manufacturing practices. Good manufacturing practices in pharmaceutical production. Good manufacturing practices for sterile pharmaceutical products. Guidelines for good storage practices. Hazard analysis and critical control point system --
Quality assurance: inspection. Pre-approval inspections. Quality systems for national GMP inspectorates --
Quality assurance: packaging. General aspects of packaging. Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals --
Quality assurance: general topics. Starting materials for pharmaceutical products: control and safe trade. Model certificate of analysis for use in trade and procurement. Tuberculosis programme: fixed-dose combinations. Comparator products for equivalence assessment of interchangeable multisource (generic) products. Measures to combat counterfeit drugs. Information on general publications --
Nomenclature and computerized systems. International nonproprietary names for pharmaceutical substances. Regulator information systems. Drug quality assurance terminology --
Regulatory issues. Harmonization of regulatory requirements --
Acknowledgements --
References --
List of available international chemical reference substances --
List of available international infrared reference spectra --
Good practices for national pharmaceutical control laboratories --
Considerations for requesting analysis of drug samples --
Basic elements of good manufacturing practices in pharmaceutical production --
Good manufacturing practices for sterile products --
Guidelines on pre-approval inspections --
Quality systems requirements for national good manufacturing practice inspectorates --
Guidelines on packaging for pharmaceutical products --
Model certificate of analysis --
Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products --
Guidelines on the use of International nonproprietary names (INNs) for pharmaceutical substances.
Series Title: Technical report series (World Health Organization), 902.
Responsibility: WHO Expert Committee on Specifications for Pharmaceutical Preparations.

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