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
Close this folderAnnex 4. Good manufacturing practices: authorized person - role, functions and training
View the document1. The role and position of the authorized person in the company
View the document2. Implementation of the quality system
View the document3. Routine duties of an authorized person
View the document4. Education and training
View the document5. Selected references
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
 

5. Selected references

Code of practice for qualified persons. In: Rules and guidance for pharmaceutical manufacturers. London, Medicines Control Agency, 1993.

Current good manufacturing practice for finished pharmaceuticals. 21 CFR Part 211.

Current good manufacturing practice in manufacturing, processing, packing or holding of drugs. General. 21 CFR Part 210.

Guideline on preparation of investigational new drug products. March 1991.

Guidelines for developing quality manuals. International Standard ISO 10013. Geneva, International Organization for Standardization, 1995.

Guide to good manufacturing practice for medicinal products. In: The rules governing medicinal products in the European Union, Volume IV. Brussels, European Commission, 1992.

Model for quality assurance in design, development, production, installation and servicing. International Standard ISO 9001. Geneva, International Organization for Standardization, 1994.

Quality management and quality assurance - vocabulary. International Standard ISO 8402. Geneva, International Organization for Standardization, 1994.

Quality management and quality system elements. International Standard ISO 9004. Geneva, International Organization for Standardization, 1994.

Second Council Directive on the approximation of provisions laid down by law: regulation of administrative action relating to proprietary medicinal products. Brussels, European Commission, 1975 (75/319/EEC).

 

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