TY  - BOOK
ED  - World Health Organization.
ED  - WHO Expert Committee on Specifications for Pharmaceutical Preparations
TI  - WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty-fifth report
T2  - WHO Technical report series,
SN  - 9789241209618
AV  - RS189 .W4753 2011
U1  - 615.1 22
PY  - 2011///
CY  - Geneva, Switzerland
PB  - World Health Organization
KW  - Drugs
KW  - Standards
KW  - Congresses
KW  - Specifications
KW  - Quality control
KW  - Pharmacopoeias
KW  - Drug Industry
KW  - standards
KW  - Pharmaceutical Preparations
KW  - Pharmacopoeias as Topic
KW  - Reference Standards
KW  - Quality Control
N1  - The WHO Expert Committee met in Geneva from October 18-22, 2010; Includes bibliographical references; Introduction -- General policy -- Joint session with the Expert Committee on Biological Standardization -- Quality control: specifications and tests -- Quality control: international reference materials (International Chemical Reference Substances and International Infrared Reference Spectra) -- Quality control: national laboratories -- Quality assurance: good manufacturing practices -- Quality assurance: new approaches -- Quality assurance: distribution and trade of pharmaceuticals -- Prequalification of priority essential medicines -- Prequalification of quality control laboratories -- Prequalification of active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Summary and recommendations -- Annexes; Also available via World Wide Web
N2  - 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 programs 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 the 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 the 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)
UR  - http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf
ER  -