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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack 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.

 

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