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
Abrir esta carpeta y ver su contenido5. Good manufacturing practices
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
Cerrar esta carpeta10. Regulatory issues
Cerrar esta carpeta10.1 WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Ver el documento10.1.1 Finished pharmaceutical products
Ver el documento10.1.2 Active pharmaceutical ingredients
Ver el documento10.2 WHO model system for computer-assisted drug registration
Ver el documento10.3 Model guidelines for the international provision of controlled medicines for emergency medical care
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
 

10.1.1 Finished pharmaceutical products

The Committee was informed that the guidelines on the scheme relating to pharmaceutical dosage forms, as published in its thirty-fourth report (14), were endorsed in Resolution EB99.R21 at the 99th session of the Executive Board in January 1997, and transmitted to the 50th World Health Assembly for adoption.1 The resolution urges Member States to implement the guidelines. Thus, importing countries should request and exporting countries should issue WHO-type product certificates as from 1 January 1998. The Committee was also informed about discussions on the scheme during the eighth International Conference of Drug Regulatory Authorities held in Bahrain in 1996. The reports given at the conference demonstrated that the use of the scheme was steadily increasing and that some regulatory authorities, including the European Medicines Evaluation Agency, were already issuing WHO-type product certificates in the revised format as published in the thirty-fourth report (14).

1 Subsequently adopted as WHA50.3, May 1997.

 

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Última actualización: le 3 mayo 2013