E-DRUG: Model Quality Assurance System for procurement agencies (MQAS) (2)
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Dear E-Druggers,
Further to the earlier message from Beverley Snell, we can provide some
additional information about the history of this WHO guidance document.
The "Model quality assurance system for procurement agencies" was
developed through WHO's standard-setting process in connection with the
WHO Expert Committee on Specifications for Pharmaceutical Preparations.
The draft guide was mailed out for feed-back worldwide, including among
the many collaborating partners and specialists also to national
regulators. It was subsequently reviewed by international experts,
taking into account the comments received during the consultation
process. Feedback was obtained from supply specialists, including those
from United Nations agencies such as UNICEF, as well as MSF, ICRC, etc.
The International Pharmaceutical Federation (FIP) participated also
actively in the drafting process. Since the consultation process lasted
for several years, the experts first adopted an interim guidance in
2003. The final guide was adopted by the members of the 40th WHO Expert
Committee on Specifications for Pharmaceutical Preparations in 2005 and
published as Annex 6 in that report (1). In accordance with the
procedure the report was presented to WHO Member States for their
implementation.
In addition, in 2003 the WHO Expert Committee members adopted the
procedure (2) that allows the assessment of procurement agencies as well
as guidelines for the preparation of a procurement agency information
file (3). Both texts are also available on the web and complete the
tools that will enable an official assessment process.
References:
(1) A model quality assurance system for procurement agencies
(Recommendations for quality assurance systems focusing on
prequalification of products and manufacturers, purchasing, storage and
distribution of pharmaceutical products)
Annex 6, WHO Technical Report Series No. 937, 2006
http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf#page=217
(2) Procedure for assessing the acceptability, in principle, of
procurement agencies for use by United Nations agencies
Annex 6, WHO Technical Report Series No. 917, 2003
http://whqlibdoc.who.int/trs/WHO_TRS_917_annex6.pdf
(3) Guidelines for the preparation of a procurement agency information
file Annex 7, WHO Technical Report Series No. 917, 2003
http://whqlibdoc.who.int/trs/WHO_TRS_917_annex7.pdf
We hope these WHO guidance documents are useful.
With best regards,
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
WHO Medicines Quality Assurance website:
http://www.who.int/medicines/areas/quality_safety/quality_assurance