WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report: 2. The international pharmacopoeia and related activities: 2.1. Quality specifications for drug substances and dosage forms

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

Table des matières

	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

2.1. Quality specifications for drug substances and dosage forms

The Committee was pleased to note that publication of Volume 4 of The international pharmacopoeia, containing additional monographs on pharmaceutical substances, excipients and dosage forms together with supporting test methods and general requirements, was expected in 1993.

The Committee considered, and recommended for inclusion in a future publication, monographs on ophthalmic drops and ointments and on suppositories, and test methods for the disintegration of suppositories and for the sterility of non-injectable preparations. It noted the progress made jointly with experts from the European Pharmacopoeia Commission on developing a test for visible particulate matter in injectable preparations.

The Committee confirmed that the requirements of The international pharmacopoeia should continue to be based on reliable methods widely available in small control laboratories. Such a policy is consistent with the unique role of The international pharmacopoeia. However, in some circumstances, the provision of more complex methods as alternatives might be considered.

It was suggested that it would be helpful for WHO to obtain information about users of The international pharmacopoeia in order to ascertain more precisely by whom and for what purposes it is currently used.