E-DRUG: Just published WHO Expert Committee report
----------------------------------------------------------------------------------------------
JUST PUBLISHED!
WHO Expert Committee on Specifications for
Pharmaceutical Preparations
Forty-eighth Report
During the 135th WHO Executive Board (EB) meeting the Report of the 48th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations was presented. Members of the EB acknowledged the outcome and expressed their thanks to the experts for their contribution to WHO's standard setting work in the area of medicines quality assurance.
The report is now available in the WHO Technical Report Series as No. 986.
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, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and
11 new International Chemical Reference Substances.
1. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals;
2. WHO good manufacturing practices for pharmaceutical products: main principles;
3. Model quality assurance system for procurement agencies, including revised versions of the
a. Model inspection report, and
b. Product questionnaire
4. Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection;
5. Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory
authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.
The Expert Committee on Specifications for Pharmaceutical Preparations reviews developments and advises the Director-General of WHO and Member States in the area of quality assurance of medicines. It provides recommendations and tools to assure the quality of medicines throughout their life-cycle from development to final distribution to patients, including international supply mechanisms. Detailed recommendations can be found under each relevant section in the report.
The publication is available as follows:
WHO Expert Committee on
Specifications for Pharmaceutical Preparations (48th) at the
price of CHF 50.00/US$ 60.00; In developing countries CHF
35.00/US$ 42.00 (order no. 11000986)
WHO, WHO Press, 1211 Geneva 27, Switzerland
Tel +41 22 791 32 64 - Fax +41 22 791 48 57 -
Email: bookorders@who.int
Web site: www.who.int/bookorders
Related web sites::
http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/
http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/en/
http://www.who.int/medicines/publications/pharmacopoeia/en/
http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/
With best regards,
Sabine Kopp
Dr Sabine Kopp | Group Lead, Medicines Quality Assurance |
HIS/EMP/RHT/TSN | Technologies Standards and Norms |
Regulation of Medicines and Other Health Technologies |
Essential Medicines and Health Products | World<http://www.rijksoverheid.nl/ministeries/vws> Health Organization |
20, Avenue Appia, CH-1211 Geneva 27 | Switzerland |
"KOPP, Sabine" <kopps@who.int>