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.