WHO Expert Committee on specifications for pharmaceutical preparations : fiftieth report

Bibliographic Details
Corporate Author: Organización Mundial de la Salud
Format: Book
Language:English
Series:(WHO technical report series ; no. 996)
Subjects:
Table of Contents:
  • 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.