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WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-ninth Report.
This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes....
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Geneva :
World Health Organization,
2005.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Preliminaries; Contents; 1 Introduction; 2 General policy; 3 Quality control specifications and tests; 4 Quality control International Reference Materials; 5 Quality control national laboratories; 6 Quality assurance good manufacturing practices; 7 Quality assurance inspection; 8 Quality assurance distribution and trade related; 9 Quality assurance risk analysis; 10 Quality assurance stability; 11 Quality assurance drug supply; 12 Regulatory guidance on interchangeability for multisource medicines; 13 Fixed dose combination products for priority communicable diseases
- 14 International Nonproprietary Names15 Summary and recommendations; Acknowledgements; International Chemical Reference Substances and International Infrared Reference Spectra1; Good manufacturing practices: requirement for the sampling of starting materials amendment; WHO Good Manufacturing Practices water for pharmaceutical use; WHO guidelines for sampling of pharmaceutical products and related materials; Guidelines for registration of fi