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
Close this folderAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Open this folder and view contents1. General remarks
Open this folder and view contents2. Training programme for inspection
Open this folder and view contents3. Training programme on examination
View the documentReferences
View the documentWorld Health Assembly resolutions
View the documentAppendix 1 The practical issues of organizing and implementing the programme
View the documentAppendix 2 Thin-layer chromatography and its application
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

References

1. Guiding principles for small national drug regulatory authorities. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-first report. Geneva, World Health Organization, 1990, Annex 6 (WHO Technical Report Series, No. 790).

2. Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996, Annex 10 (WHO Technical Report Series, No. 863).

3. Guidelines for inspection of drug distribution channels. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fifth report. Geneva, World Health Organization, 1999, Annex 6 (WHO Technical Report Series, No. 885).

Useful documents

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

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

Considerations on the use of simple test methods to detect counterfeit pharmaceutical products. Geneva, World Health Organization, 1995 (unpublished document DRS/QAS/95.1).1

Counterfeit pharmaceuticals. Report of a joint WHO/IFPMA Workshop 1-3 April 1992. Geneva, World Health Organization, 1992 (unpublished document WHO/DMP/CFD/92).1

Detection of counterfeit pharmaceuticals and simple tests for pharmaceutical products. Geneva, World Health Organization, 1995 (unpublished document PHARM/95.299/rev.1).1

Extracts from the document "Research and development of rapid examinations of fake drugs" 1993-1994. International Affairs Division, Minister's Secretariat, Ministry of Health and Welfare. Japan. Geneva, World Health Organization, 1995 (unpublished document PHARM/95.305).1

Guidelines on import procedures of pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996. Annex 12 (WHO Technical Report Series, No. 863).

Kenyon AS, Layloff TP. Screening of pharmaceuticals by thin-layer chromatography. Geneva, World Health Organization, 1995 (unpublished document PHARM/95.290).1

Niebruegge LD, Juhl WE. Physical characterization of tablets and capsules. St Louis, FDA, Division of Drug Analysis, 1990 (FDA/ORA/Laboratory Information Bulletin 3566).

Research and development of rapid examinations for fake drugs 1993-1994. International Affairs Division, Minister's Secretariat, Ministry of Health and Welfare, Japan (unpublished document PHARM/96.341).1

Sampling procedure for industrially manufactured pharmaceuticals. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-first report. Geneva, World Health Organization, 1990, Annex 2 (WHO Technical Report Series, No. 790).

Simple tests for drugs included in the WHO model list of essential drugs. Geneva, World Health Organization, 1995 (unpublished document PHARM/95.583/rev.1).1

Simple thin-layer chromatographic identification of active ingredients in essential drugs. Aulendorf, German Pharma Health Fund, 1994.

Summary of WHO counterfeit drug database as of October 1996. Geneva, World Health Organization (unpublished document).1

The rational use of drugs. Report of the Conference of Experts, Nairobi. Geneva, World Health Organization, 1987.

Training programme in drug analysis for counterfeit pharmaceuticals. Geneva, World Health Organization, 1996 (unpublished document PHARM/96.340).1

1 Available on request from Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland.

 

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