WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report: 7. Development of globally acceptable standards for excipients

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

7. Development of globally acceptable standards for excipients

The Committee recommended that WHO should use its worldwide channels of communication to inform interested parties of the action being taken to harmonize the specifications for certain excipients in the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopoeia. Those so informed should send any comments on the proposed harmonized specifications to whichever of the three pharmacopoeial authorities was taking the lead on the monograph in question. Once such harmonized texts were adopted by the three pharmacopoeias, the need for a monograph in The international pharmacopoeia or, where such a monograph existed, for its revision, could be considered.