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
 

Annex 4. Good manufacturing practices: authorized person - role, functions and training

This text does not constitute additional requirements in the area of good manufacturing practices (GMP). It is intended to assist manufacturers wishing to strengthen their quality assurance systems. References to ISO standards of the 9000 series are relevant primarily to manufacturers not in a position to implement full GMP requirements immediately. The reason for this may be lack of resources or a limited involvement in contractual manufacturing/testing of drugs. For such manufacturers/testing laboratories, the implementation of quality systems along the lines of ISO standards will be a step in the right direction. Manufacturers fully complying with GMP requirements may wish to adopt on a voluntary basis certain elements found in ISO standards of the 9000 series, e.g. quality manuals. Nothing in this text should be interpreted as a suggestion that drug manufacturers need external certification under ISO standards.

The GMP guidelines published by WHO1 define the authorized person as a person (among key personnel of a manufacturing establishment) responsible for the release of batches of finished products for sale. In some other GMP guides and legal texts the term qualified person is used to describe analogous functions.

1 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).

 

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