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_44meetingsreport/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