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003 NULRC
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020 _a9789241209618
040 _cNULRC
050 _aRS 51 .W67 2011
245 0 _aWHO Expert Committee on specializations for pharmaceutical preparations :
_bforty-fifth report.
260 _aGeneva, Switzerland :
_bWorld Health Organization,
_cc2011
300 _aiii, 428 pages :
_billustrations ;
_c24 cm.
504 _aIncludes bibliographical references.
505 _aIntroduction -- 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
650 _aPHARMACEUTICAL PREPARATIONS -- STANDARDS
942 _2lcc
_cBK
999 _c11720
_d11720