E-DRUG: New WHO medicines quality assurance guidelines and specifications
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Dear colleagues,
we are happy to announce the following NEWS:
The report of the 44th WHO Expert Committee on Specifications for
Pharmaceutical Preparations is now available as a WHO publication on the
WHO web site as follows:
http://www.who.int/medicines/publications/44threport/en/index.html
During its 44th meeting the experts adopted 42 new monographs for
inclusion in The International Pharmacopoeia (Ph.Int.) and nine related
International Chemical Reference Standards (ICRS). The specifications
under development are internationally applicable test methodologies for
antimalarials, antituberculosis medicines, antiretrovirals,
radiopharmaceuticals and specifically also medicines for children.
In addition, seven new quality assurance guidelines were adopted and are
included in the report as follows:
* WHO good practices for pharmaceutical quality control laboratories (Annex 1)
* WHO good manufacturing practices for active pharmaceutical ingredients (Annex 2)
* WHO good manufacturing practices for pharmaceutical products containing hazardous substances (Annex 3)
* WHO good manufacturing practices for sterile pharmaceutical products (Annex 4)
* WHO good distribution practices for pharmaceutical products (Annex 5)
* Guidelines on the requalification of prequalified dossiers (Annex 6)
* Guidelines for the preparation of a contract research organization master file (Annex 7)
The WHO Expert Committee on Specifications for Pharmaceutical
Preparations advises the Director-General in the area of quality
assurance of medicines. It provides recommendations and tools to assure
the quality of medicines from their development phase to their final
distribution to the patients.
This WHO Expert Committee looks back on a history of more than 60 years!
The first meeting of the Expert Committee, named "Unification on
Pharmacopoeias" at that time, was held in 1947. Since the inception of
this WHO Expert Committee, its members have worked towards making
available clear, independent and practical recommendations, written and
physical standards, as well as international guidelines for quality
medicines.
These international guidelines, specifications and nomenclature
developed under the aegis of this Committee serve all Member States,
international organizations, United Nations agencies, regional and
interregional harmonization efforts, and underpin important initiatives,
including the prequalification of medicines, the Roll Back Malaria
Programme, Stop TB, essential medicines and medicines for children. The
advice and recommendations provided by this Expert Committee are
intended to help national and regional authorities and procurement
agencies, as well as major international bodies and institutions, such
as the Global Fund to Fight AIDS, Tuberculosis and Malaria, and
international organizations such as UNICEF - to combat circulation of
substandard medicines and to work towards access to quality medicines.
Dr Sabine Kopp
Manager
Medicines Quality Assurance Programme
Quality Assurance & Safety: Medicines
World Health Organization
20, av. Appia
CH-1211 Geneva 27
Fax: +41 22 791 4730
"Kopp, Sabine" <kopps@who.int>