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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
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
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. The use of essential drugs. Eighth report of the WHO Expert Committee (including the revised Model List of Essential Drugs). Geneva, World Health Organization, 1998 (WHO Technical Report Series, No. 882).

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

3. Basic tests for pharmaceutical substances. Geneva, World Health Organization, 1986.

4. Basic tests for pharmaceutical dosage forms. Geneva, World Health Organization, 1991.

5. The international pharmacopoeia, 3rd ed., Vol. 1. General methods of analysis. Geneva, World Health Organization, 1979.

6. The international pharmacopoeia, 3rd ed., Vol. 2. Quality specifications. Geneva, World Health Organization, 1981.

7. The international pharmacopoeia, 3rd ed., Vol. 3. Quality specifications. Geneva, World Health Organization, 1988.

8. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823).

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

10. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtieth report. Geneva, World Health Organization, 1987 (WHO Technical Report Series, No. 748).

11. Recommendations on a quality system for official medicines control laboratories. Geneva, Pharmaceutical Inspection Convention, 1995 (document PH 2/95; available from EFTA Secretariat, 9-11, rue de Varembé, 1211 Geneva 20, Switzerland).

12. Recommendations on quality system requirements for GMP inspectorates of PIC Contracting States. Geneva, Pharmaceutical Inspection Convention, 1994 (document PH 7/94; available from EFTA Secretariat, 9-11, rue de Varembé, 1211 Geneva 20, Switzerland).

13. Considerations on the use of simple test methods to detect counterfeit pharmaceutical products. Geneva, World Health Organization, 1995 (unpublished document DRS/QAS/95.1; available from Drug Safety, Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

14. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996 (WHO Technical Report Series, No. 863).

15. International nonproprietary names (INN) for pharmaceutical substances: lists 1-73 of proposed INN and lists 1-35 of recommended INN; cumulative list no. 9. Geneva, World Health Organization, 1996.

16. The graphic representation of chemical formulae in the publications of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva, World Health Organization, 1995 (unpublished document WHO/PHARM/95.579; available from Quality Assurance, Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

17. Standard terms, pharmaceutical dosage forms, routes of administration, containers. Strasbourg, European Department for the Quality of Medicines and the European Pharmacopoeia, 1996 (ISSN 1013-5294).

18. Pharmacological action and therapeutic use of drugs - list of terms. Geneva, World Health Organization, 1997 (unpublished document WHO/PHARM/97.594; available from Quality Assurance, Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

19. WHO model system for computer-assisted drug registration: a brief description and user manual. Geneva, World Health Organization, 1996 (unpublished document available from Operational Drug Registration, Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland).

20. Model guidelines for the international provision of controlled medicines for emergency medical care. Geneva, World Health Organization. 1996 (unpublished document WHO/PSA/96.17; available from Department of Substance Abuse, WHO, 1211 Geneva 27, Switzerland).

 

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