Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Open this folder and view contentsStability of drug dosage forms1
Close this folderGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
View the documentGeneral
View the documentDefinitions
View the document1. Stability testing
View the document2. Intended market
View the document3. Design of stability studies
View the document4. Analytical methods
View the document5. Stability report
View the document6. Shelf-life and recommended storage conditions
View the documentReferences
View the documentOfficial, international and national guidelines
View the documentAppendix 1. Survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs: answer sheet
View the documentAppendix 2. Stability testing: summary sheet
Open this folder and view contentsMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover

4. Analytical methods

A systematic approach should be adopted to the presentation and evaluation of stability information, which should include, as necessary, physical, chemical, biological and microbiological test characteristics.

All product characteristics likely to be affected by storage, e.g. assay value or potency, content of products of decomposition, physicochemical properties (hardness, disintegration, particulate matter, etc.), should be determined; for solid or semi-solid oral dosage forms, dissolution tests should be carried out.

Test methods to demonstrate the efficacy of additives, such as antimicrobial agents, should be used to determine whether such additives remain effective and unchanged throughout the projected shelf-life.

Analytical methods should be validated or verified, and the accuracy as well as the precision (standard deviations) should be recorded. The assay methods chosen should be those indicative of stability. The tests for related compounds or products of decomposition should be validated to demonstrate that they are specific to the product being examined and are of adequate sensitivity.

A checklist similar to that used in the WHO survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs (Appendix 1) can be used to determine the other stability characteristics of the product.

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