WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] 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 issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
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 Spectra1
Close this folderAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
View the documentIntroduction
Open this folder and view contentsPart A. Primary chemical reference substances
View the documentPart B. Secondary chemical reference substances
View the documentReferences
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

References

1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twenty-fifth report. Geneva, World Health Organization, 1975, Annex 3 (WHO Technical Report Series, No. 567).

2. The international pharmacopoeia, 3rd ed. Vol. 1. General methods of analysis; Vol. 2. Quality specifications; Vol. 3. Quality specifications; Vol. 4. Tests, methods, and general requirements. Quality specifications for pharmaceutical substances, excipients, and dosage forms. Geneva, World Health Organization, 1979-1994.

3. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twenty-eighth report. Geneva, World Health Organization, 1982, Annex 1 (WHO Technical Report Series, No. 681).

4. Good laboratory practices in governmental drug control laboratories. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtieth report. Geneva, World Health Organization, 1987, Annex 1 (WHO Technical Report Series, No. 748).

5. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).

6. Good manufacturing practices for biological products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-third report. Geneva, World Health Organization, 1993, Annex 3 (WHO Technical Report Series, No. 834).

7. General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996, Annex 4 (WHO Technical Report Series, No. 863).

 

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