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
Close this folder8. Stability of dosage forms
View the document8.1. Survey
View the document8.2. Guidelines on stability testing of pharmaceutical products containing established drug substances
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
 

8.2. Guidelines on stability testing of pharmaceutical products containing established drug substances

In response to the Committees earlier request (2), the draft WHO guidelines on stability testing were reviewed. It was emphasized that these guidelines should be consistent with those in course of preparation within the ICH programme with respect to all technical definitions and other related issues. The focus of the WHO guidelines, however, would be on providing advice on the stability testing of formulations containing established drug substances intended for use in the more extreme climatic conditions frequently encountered in many developing countries.

 

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