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Envoyé : mardi 31 mai 2011 15:31
ForPharmaceutical Preparations
E-drug: 45th WHO Expert Committee On Specifications For Pharmaceutical
Preparations
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FORTY-FIFTH WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL
PREPARATIONS
The World Health Organization (WHO) Medicines Quality Assurance Programme is
happy to announce that the 45th report of the WHO Expert Committee on
Specifications for Pharmaceutical Preparations was presented to the WHO
Executive Board on 25 May 2011 and is now available for use and
implementation.
(Ref.: http://apps.who.int/gb/ebwha/pdf_files/EB129/B129_10-en.pdf)
The following new guidelines were adopted and are included in this report:
* Procedure for adoption of International Chemical Reference
Substances (ICRS (Annex 1, revised)
* Good Practices for Pharmaceutical Microbiology Laboratories (Annex
2, new)
* GMP: main principles (Annex 3, updated)
* GMP for blood establishments (jointly with ECBS) (Annex 4, new)
* Supplementary GMP for HVAC (Annex 5, updated)
* GMP for sterile pharmaceutical products (Annex 6, updated)
* Guiding principles on transfer of technology in pharmaceutical
manufacturing. (Annex 7, new)
* Good Pharmacy Practice: standards for quality of pharmacy services
(joint FIP/WHO, Annex 8, updated)
* Model guidance for the storage and transport of time- and
temperature sensitive pharmaceutical products (Annex 9, new)
* Procedure for prequalification of pharmaceutical products (Annex 10,
updated)
* Guidance on submission of documentation for prequalification of
innovator FPPs approved by stringent regulatory authorities (Annex 11, new)
* Procedure for prequalification of laboratories (Annex 12, updated)
* WHO guidelines for preparing a laboratory information file (Annex
13, updated)
* Guidelines for preparing a Site Master File (Annex 14, new)
* Guideline for submission of documentation for a multisource
(generic) finished product (Annex 15, new)
In addition, 25 new monographs and texts were adopted for inclusion in The
International Pharmacopoeia. The specifications under development are
internationally applicable methods for testing antimalarial,
antituberculosis, antiretroviral and radiopharmaceutical medicines, as well
as medicines for children.
The full report is available n the following web site:
http://www.who.int/medicines/publications/pharmprep/en/index.html
--> http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf
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Hard copies can be obtained via WHO Press.
More information about the Committee can be found at:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/en/index
.html
http://www.who.int/medicines/services/expertcommittees/pharmprep/ep_44meetin
gsreport/en/index.html
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The WHO Expert Committee on Specifications for Pharmaceutical Preparations
provides, since more than 60 years, recommendations and tools to assure the
quality of medicines from their development phase to their final
distribution to patients. The report includes joint activities, specifically
with the WHO Expert Committee on Biological Standardization, and on the
Selection and Use of Essential Medicines and its Subcommittee on Medicines
for Children. This Committee also serves the United Nations Programme on
Prequalification of Medicines managed and operated by WHO.
Regarding implementation from a wider perspective, the 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 the United Nations
Children's Fund (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
kopps@who.int