WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoWHO Expert Committee on Specifications for Pharmaceutical Preparations
Ver el documento1. Introduction
Abrir esta carpeta y ver su contenido2. The international pharmacopoeia and related issues
Abrir esta carpeta y ver su contenido3. International Chemical Reference Substances and Infrared Reference Spectra
Abrir esta carpeta y ver su contenido4. Quality control - national laboratories
Cerrar esta carpeta5. Good manufacturing practices
Ver el documento5.1 Adoption of additional guidelines
Ver el documento5.2 Good manufacturing practices for sterile products
Ver el documento5.3 Relationship between pharmacopoeial requirements and manufacturers' internal specifications
Abrir esta carpeta y ver su contenido6. Quality systems and inspection
Abrir esta carpeta y ver su contenido7. Other quality assurance topics
Abrir esta carpeta y ver su contenido8. Nomenclature and terminology
Abrir esta carpeta y ver su contenido9. Legal aspects of pharmaceuticals
Abrir esta carpeta y ver su contenido10. Regulatory issues
Abrir esta carpeta y ver su contenido11. Training activities
Ver el documento12. Pharmaceuticals contaminated with diethylene glycol
Ver el documentoAcknowledgements
Ver el documentoReferences
Ver el documentoAnnex 1. List of available International Chemical Reference Substances1
Ver el documentoAnnex 2. List of available International Infrared Reference Spectra1
Abrir esta carpeta y ver su contenidoAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Abrir esta carpeta y ver su contenidoAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Abrir esta carpeta y ver su contenidoAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Abrir esta carpeta y ver su contenidoAnnex 6. Guidelines for inspection of drug distribution channels
Ver el documentoAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Abrir esta carpeta y ver su contenidoAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Abrir esta carpeta y ver su contenidoAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Ver el documentoWorld Health Organization Technical Report Series
Ver el documentoSelected WHO Publications of Related Interest
Ver el documentoBack Cover
 

5.1 Adoption of additional guidelines

The Committee adopted two supplements to the GMP guidelines published as Annex 1 to its thirty-second report (8); these texts provide additional advice on the role, functions and training of the "authorized person" (Annex 4), and on the manufacture of pharmaceutical excipients (Annex 5). In adopting the guidelines on the authorized person, the Committee emphasized that this text did not represent additional requirements in the area of GMP. It was offered as advice to manufacturers wishing to strengthen their existing quality assurance systems.

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Última actualización: le 3 mayo 2013