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
 

4. Education and training

The pool of expertise drawn upon for candidates for the position of authorized person may differ from country to country. The basic qualifications of a scientific education and practical experience for key personnel, including authorized persons, are outlined in the GMP guidelines published by WHO (section 10, Personnel).

Additional requirements may include subjects such as principles of quality assurance and GMP, principles of good laboratory practice as applicable to research and development as well as to quality control, detailed knowledge of the authorized/qualified person's duties and responsibilities, of International Standards ISO 9000-9004 and relationships with suppliers, principles and problems of formulation of pharmaceutical preparations, pharmaceutical microbiology, and principles and practice of sampling and testing of starting materials, packaging components and finished dosage forms. For a more detailed list of issues consult the selected references.

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