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WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-second Report.
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for medicines' quality assurance. Standards are developed by the Committee through worldwide consultation and an international consensus building proces...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Geneva :
World Health Organization,
2008.
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| Colección: | Technical Report Series, No. 948.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Preliminaries; Contents; 1 Introduction; 2 General policy; 3 Quality control specifi cations and tests; 4 Quality control International Chemical Reference Substances and International Infrared Reference Spectra; 5 Quality control national laboratories; 6 Quality assurance good manufacturing practices; 7 Quality assurance new approaches and risk analysis; 8 Quality assurance distribution and trade of pharmaceuticals; 9 Quality assurance stability; 10 Prequalifi cation of priority essential medicines and devices; 11 Prequalifi cation of active pharmaceutical ingredients.
- 12 Prequalifi cation of quality control laboratories13 Active pharmaceutical ingredient master fi le; 14 Regulatory guidance; 15 Nomenclature terminology and databases; 16 Miscellaneous; 17 Summary and recommendations; Acknowledgements; and International Infrared Reference Spectra; condoms for purchase by United Nations agencies; intrauterine devices for purchase by United Nations agencies; Guidelines on active pharmaceutical ingredient mas.