WHO Expert Committee on specifications for pharmaceutical preparations : fiftieth report
Autor Corporativo: | |
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Formato: | Libro |
Lenguaje: | English |
Colección: | (WHO technical report series ;
no. 996) |
Materias: |
Tabla de Contenidos:
- Introduction. – General policy. – Quality control-specifications and tests. – Quality control-international reference materials /International Chemical Reference Substance and Infrared Reference Spectra). – Quality control-national laboratories. – Prequalification of quality control laboratories. – Quality assurance-collaboration initiatives. – Quality assurance-good manufacturing practices. – Auality assurance-distribution and trade of pharmaceuticals. – Prequalification of priority essential medicines and active pharmaceutical ingredients. – Regulatory guidance. – Nomenclature, terminology and databases. – Summary and recommendations.