By World Health Organization
This document offers the options of a global staff of specialists convened by way of the area overall healthiness association to contemplate concerns in regards to the caliber insurance of prescribed drugs and requirements for drug elements and dosage kinds. The document is complemented through a few annexes. those comprise: an inventory of obtainable overseas chemical reference components and foreign infrared spectra; supplementary guidance on solid production practices for heating, air flow and air-conditioning structures for non-sterile pharmaceutical dosage varieties; up to date supplementary instructions on reliable production practices for the manufacture of natural medicinal drugs; supplementary instructions on solid production practices for validation; sturdy distribution practices for pharmaceutical items; a version caliber coverage method for procurement companies (recommendations for caliber coverage platforms concentrating on prequalification of goods and brands, procuring, garage and distribution of pharmaceutical products); multisource (generic) pharmaceutical items: guidance on registration standards to set up interchangeability; an offer to waive in vivo bioequivalence specifications for WHO version record of crucial medicinal drugs immediate-release, good oral dosage types; and extra advice for corporations acting in vivo bioequivalence reviews.
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Additional info for WHO Expert Committee on Specifications for Pharmaceutical Preparations (40th report)
Example text
Briggs, Director, Office of Complementary Medicines, Therapeutic Goods Administration, Commonwealth Department of Health and Family Services, Woden, Australia; Dr D. Calam, Wiltshire, England; Mr P. Castle, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France; Mr G. Catto, World Federation of Proprietary Medicine Manufacturers, London, England; Dr P. Chan, Director, Bureau of Products Review and Assessment, Natural Health Products and Food Branch, Health Canada, Ottawa, Ontario, Canada; Dr B.
Cone, PJB Publications Ltd, Richmond, England; Dr E. Coquillette, Secretariat Committee for Herbal Medicinal Products, European Medicines Agency, London, England; Dr J. M. P. Cou, Pharmaceutical Affairs Department, Macau SAR, People’s Republic of China; Dr P. Cox, Consultant in Nuclear Medicine and Radiopharmacy, Bexhill-on-Sea, East Sussex, England; Dr P. Cranston, Australian Self Medication Industry, Sydney, Australia; Dr E. J. 2006 15:16:59 Global Regulatory Affairs, Cheshire, England; Ms F.
E. Pino Arango, Ministry of Health, Bogotá, Colombia; Dr J. Pogány, Budapest, Hungary; Dr W. Pohler, Pharmaceutical Sciences, Aventis Pharma, Frankfurt am Main, Germany; Miss A. Poompanich, Division of Drug Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Dr H. Potthast, Federal Institute for Drugs and Medical Devices, Bonn, Germany; Dr S. Pramono, Department of Pharmaceutical Biology, Faculty of Pharmacy, Gadjah Mada University, Yogyakarta, Indonesia; Dr S.
