WHO Expert Committee on specifications for pharmaceutical preparations : fiftieth report

Detalles Bibliográficos
Autor Corporativo: Organización Mundial de la Salud
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.