WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-seventh Report : 37th Report.
Başlık:
WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-seventh Report : 37th Report.
Yazar:
Organization, World Health.
ISBN:
9789240681576
Yazar Ek Girişi:
Fiziksel Tanımlama:
1 online resource (145 pages)
İçerik:
Front matter -- Contents -- 1. Introduction -- 2. General policy -- 2.1 Specifications for medicinal plant materials and for herbal products -- 2.2 Risk of transmitting animal spongiform encephalopathy agents via medicinal products -- 2.3 Stop TB programme -- 2.4 Roll Back Malaria programme -- 2.5 HIV/AIDS programme -- 2.6 Future of The International Pharmacopoeia -- 2.7 Pharmacopoeial Discussion Group (PDG) -- 2.8 International Conference on Harmonisation (ICH) -- 3. Quality control - specifications and tests -- 3.1 Thin-layer chromatography screening tests for antimalarials -- 3.2 Radiopharmaceuticals -- 3.3 Pharmacopoeial monographs on antiretrovirals -- 3.4 Thin-layer chromatography screening tests for antituberculosis drugs -- 3.5 Draft monograph on rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride tablets -- 4. Quality control - international reference materials -- 5. Quality control - national laboratories -- 5.1 External quality assessment scheme -- 5.2 Cost estimate of equipment for model quality control laboratories -- 6. Quality assurance - good manufacturing practices -- 6.1 Specific GMP guidelines for radiopharmaceutical products -- 6.2 GMP guidelines for active pharmaceutical ingredients -- 6.3 WHO GMP: main principles for pharmaceutical products -- 6.4 WHO basic training modules on GMP -- 7. Quality assurance - inspection -- 7.1 Model certificate of GMP -- 7.2 Guidance for GMP inspection report -- 8. Quality assurance - distribution and trade-related -- 8.1 Good trade and distribution practices of pharmaceutical starting materials -- 8.2 WHO Scheme for the Certification of Pharmaceutical Starting Materials Moving in International Commerce: guidelines on implementation -- 8.3 WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce -- 9. Quality assurance - risk analysis.
9.1 Risk analysis in quality control and impurities -- 9.2 Application of hazard analysis and critical control point methodology for pharmaceuticals -- 10. Quality assurance - drug supply -- 10.1 Procedure for assessing the acceptability for purchase of pharmaceutical products -- 10.2 Procedure for assessing the acceptability for purchase of pharmaceutical products for the treatment of HIV/AIDS -- 11. Quality assurance - storage -- 11.1 WHO guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms -- 11.2 Good storage practices -- 12. International Nonproprietary Names (INNs) programme -- 13. Miscellaneous -- 13.1 Proposal to the WHO Expert Committee by the Scientific Working Group on Bioequivalence of the International Pharmaceutical Federation (FIP) -- 13.2 Dissolution tests for quality control -- 13.3 Electronic version of publications -- 13.4 Standardized reporting sheet -- 13.5 Distribution of documents for procedural consultation process -- Acknowledgements -- References -- Annex 1 Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products -- Annex 2 The International Pharmacopoeia: revised concepts and future perspectives -- Annex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products -- Annex 4 Good Manufacturing Practices for pharmaceutical products: main principles -- Annex 5 Model certificate of Good Manufacturing Practices -- Annex 6 Guidance on Good Manufacturing Practices (GMP): inspection report -- Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals -- Annex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies -- Annex 9 Guide to good storage practices for pharmaceuticals.
Özet:
This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.
Notlar:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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