WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-fifth Meeting Report
Technical Report Series, No 961
World Health Organization
ISBN-13    9789241209618 ISBN-10    9241209615
Order Number    11000961 Format    Paper Back
Price    CHF    70.00 / US$    84.00 Developing countries:    CHF    49.00
English     2011        440   pages
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This report gives recommendations and provides independent international standards and guidelines in the area of quality assurance for implementation by WHO Member States, international organizations, United Nations agencies, regional and interregional harmonization efforts, as well as WHO's medicines' related programmes and initiatives.

During the 45th meeting the following new and revised guidelines were adopted and are thus annexed to the report: Procedure for adoption of ICRS (revised), Good Pharmacy Practice (joint FIP/WHO, revised), Guidance for Pharmaceutical Microbiology laboratories (new), Procedure for prequalification of laboratories (revised), WHO guidelines for preparing a laboratory information file, GMP: main principles (revised), GMP for blood establishments (jointly with ECBS), GMP for HVAC (revised), GMP for sterile pharmaceutical products (revised), Guidelines for preparing a Site Master File (new), Guiding principles on transfer of technology (new), Model guidance for the storage and transport of time- and temperature sensitive pharmaceutical products (new, jointly with ECBS), Guidance on submission of documentation for prequalification of innovator FPPs approved by stringent regulatory authorities (new), Procedure for prequalification of medicines (revised), Guideline for submission of documentation for a multisource (generic) finished product (new) and Special guidance for artemisinin as a starting material for production of antimalarials (subject to confirmation of impurity profile, new).