TY  - BOOK
TI  - WHO Expert Committee on specifications for pharmaceutical preparations : forty-first report
T2  - WHO Technical Report Series
SN  - 9789241209434
AV  - RS 51 .W67 2007 
PY  - 2007///
CY  - Geneva
PB  - World Health Organization
KW  - DRUGS QUALITY CONTROL
KW  - DRUGS STANDARD
N1  - Includes bibliographical references; Introduction -- General Policy -- Quality control- specifications and tests -- Quality control- International Reference Materials -- Quality control- national laboratories -- Quality assurance- Good Manufacturing practices -- Quality assurance- inspection -- Quality assurance- distribution and trade related -- Quality assurance- risk analysis -- Quality assurance- Stability -- Prequalification -- Regulatory guidance -- Nomenclature and computerized systems -- Miscellaneous -- Summary and recommendations
N2  - This report includes the following guidelines of direct relevance to the United Nations Prequalification Programme for Priority Essential Medicines and for quality control laboratories: procedures governing the assessment of pharmaceutical products for procurement by United Nations agencies and for assessing the acceptability of quality control laboratories for use by United Nations agencies, as well as guidance on variations to a prequalified product dossier.
ER  -