WHO Technical Report Series Series 1010

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fifty-second Report

May 2018
More details
  • Publisher
    World Health Organization
  • Published
    17th May 2018
  • ISBN 9789241210195
  • Language English
  • Pages 418 pp.
  • Size 6.25" x 9.4"

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:

- WHO guidelines on good herbal processing practices for herbal medicines;
- Guidelines on good manufacturing practices for the manufacture of herbal medicines;
- Considerations for requesting analysis of medicine samples;
- WHO model certificate of analysis;
- WHO guidance on testing of "suspect" falsified medicines;
- Good pharmacopoeial practices - Chapter on monographs for compounded preparations;
- Good pharmacopoeial practices - Chapter on monographs on herbal medicines;
- Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products;
- Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions;
- Stability testing of active pharmaceutical ingredients and finished pharmaceutical products; and
- Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities.

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.