WHO Technical Report Series Series 1019

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fifty-third report

May 2019
More details
  • Publisher
    World Health Organization
  • Published
    29th May 2019
  • ISBN 9789241210287
  • Language English
  • Pages 299 pp.
  • Size 6" x 9"

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating, ventilation and air-conditioning systems (HVAC) illustrative part; Guidance on GMP for Validation, including the general main text, analytical procedure validation, validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification systembased classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.

World Health Organization

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.