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 : References

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

References

1. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823), Annex 1.

2. WHO Expert Committee on Biological Standardization. Forty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822).

3. Laboratory biosafety manual, 2nd ed. Geneva, World Health Organization, 1993.

4. Quality management for chemical safety testing. Geneva, World Health Organization, 1992 (Environmental Health Criteria, No. 141).

5. WHO Expert Committee on Biological Standardization. Fortieth Report. Geneva, World Health Organization, 1990 (WHO Technical Report Series, No. 800), Annex 1.

SELECTED WHO PUBLICATIONS OF RELATED INTEREST

The international pharmacopoeia, third edition.	Price (Sw.fr.)*
Volume 1: general methods of analysis. 1979 (223 pages)	24-
Volume 2: quality specifications. 1981 (342 pages)	36-
Volume 3: quality specifications. 1988 (407 pages)	64-
Basic tests for pharmaceutical dosage forms. 1991 (v + 129 pages)	24.-
Basic tests for pharmaceutical substances. 1986 (205 pages)	34.-
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. WHO Technical Report Series, No. 823, 1992 (vi + 134 pages)	17.-
The use of essential drugs. Fifth report of the Expert Committee. WHO Technical Report Series, No. 825, 1992 (iv + 75 pages)	10.-
International nonproprietary names (INN) for pharmaceutical substances. Cumulative list No. 8. 1992 (xlvi + 692 pages)	140-
Biological substances: International Standards and Reference Reagents, 1990. 1991 (105 pages)	19-
Guidelines for developing national drug policies. 1988 (iv + 52 pages)	11-
Ethical criteria for medicinal drug promotion. 1988 (16 pages)	8.-
WHO Expert Committee on Biological Standardization. Forty-second report. WHO Technical Report Series, No. 822, 1992 (v + 84 pages)	12-
WHO Expert Committee on Biological Standardization. Forty-first report. WHO Technical Report Series, No. 814, 1991 (v + 79 pages)	11.-

* Prices in developing countries are 70% of those listed here.

Further information on these and other WHO publications can be obtained from
Distribution and Sales, World Health Organization, 1211 Geneva 27, Switzerland