WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report: Annex 3 - Good manufacturing practices for biological products 1 : Acknowledgements

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages)

Table of Contents

	WHO Expert Committee on Specifications for Pharmaceutical Preparations
	1. Introduction
	2. The international pharmacopoeia and related activities
		2.1. Quality specifications for drug substances and dosage forms
		2.2. Dissolution test for solid oral dosage forms: paddle method
		2.3. Therapeutic equivalence of multisource products
		2.4. International nonproprietary names for pharmaceutical substances
	3. International Chemical Reference Substances and International Infrared Reference Spectra
		3.1. Establishment of reference substances
		3.2. Infrared reference spectra
	4. Quality control methods for medicinal plant materials
	5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
	6. Good manufacturing practices for pharmaceutical products
		6.1. Biological products
		6.2. Herbal medicinal products
		6.3. Process validation
		6.4. Further developments
	7. Development of globally acceptable standards for excipients
	8. Stability of dosage forms
		8.1. Survey
		8.2. Guidelines on stability testing of pharmaceutical products containing established drug substances
	9. Simple test methodology
	10. Quality assurance in pharmaceutical supply systems
	11. Pharmaceutical production in developing countries
		11.1. Small-scale preparation of ophthalmic (eye) drops
		11.2. Production of hormonal contraceptives
	12. Training
	Acknowledgements
	References
	Annex 1 - List of available International Chemical Reference Substances¹
	Annex 2 - List of available International Infrared Reference Spectra
	Annex 3 - Good manufacturing practices for biological products¹
		1. Scope of these guidelines
		2. Principles
		3. Personnel
		4. Premises and equipment
		5. Animal quarters and care¹
		6. Production
		7. Labelling
		8. Lot processing records (protocols) and distribution records
		9. Quality assurance and quality control
		Authors
		Acknowledgements
		References
	Back Cover

Acknowledgements

Acknowledgements are due to the following experts for their comments and advice on the draft of “Good manufacturing practices for biological products”: Professor I. Addae-Mensah, Chemistry Department, University of Ghana, Accra, Ghana; Professor H. Blume, German Pharmacists’ Central Laboratory, Eschborn, Germany; Dr A. Fenyves, Paul Ehrlich Institute, Langen, Germany; Dr C. Guthrie, General Manager, Blood Products Division, CSL Ltd., Parkville, Australia; Dr U. Ihrig, German Pharmacists’ Central Laboratory, Eschborn, Germany; Mr K. Kawamura, Takeda Chemical Industries Ltd., Nihonbashi, Chuo-ku, Tokyo, Japan; Mr L G. Kinnander, Chief Pharmaceutical Inspector, Medical Products Agency. Uppsala, Sweden; Mrs S. F. Langlois, Director, Regulatory Affairs, Connaught Laboratories Ltd., A Pasteur Mérieux Company, Willowdale, Ontario, Canada; Mr P. Lemoine, Institute of Hygiene and Epidemiology, Brussels, Belgium; Mr J. Lyng, State Serum Institute, Copenhagen, Denmark; Professor N.V Medunitsin, Director, Tarasevich State Institute for the Standardization and Control of Medical Biological Preparations, Moscow, USSR; Dr R. Netter, Paris, France: Professor A. A. Olaniyi, Pharmaceutical & Chemistry Department, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria.