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010   $a1-281-74403-4
010   $a9786611744038
010   $a92-4-068310-0
035   $a(CKB)1000000000690056
035   $a(EBL)349986
035   $a(OCoLC)476167593
035   $a(MiAaPQ)EBC349986
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035   $a(OCoLC)437213722
035   $a(EXLCZ)991000000000690056
100   $a20080903d2008      uy             0
101 0 $aeng
135   $aurcn|||||||||
200 00$aWHO Expert Committee on Specification for Pharmaceutical Preparations$b[electronic resource] $eforty-second report
210   $aGeneva, Switzerland $cWorld Health Organization$d2008
215   $a1 online resource (150 p.)
225 1 $aWHO technical report series,$x0512-3054 ;$v948
300   $aDescription based upon print version of record.
311   $a92-4-120948-8 
320   $aIncludes bibliographical references.
327   $aPreliminaries; Contents; 1 Introduction; 2 General policy; 3 Quality control specifications and tests; 4 Quality control International Chemical Reference Substances and International Infrared Reference Spectra; 5 Quality control national laboratories; 6 Quality assurance good manufacturing practices; 7 Quality assurance new approaches and risk analysis; 8 Quality assurance distribution and trade of pharmaceuticals; 9 Quality assurance stability; 10 Prequalification of priority essential medicines and devices; 11 Prequalification of active pharmaceutical ingredients
327   $a12 Prequalification of quality control laboratories 13 Active pharmaceutical ingredient master file; 14 Regulatory guidance; 15 Nomenclature terminology and databases; 16 Miscellaneous; 17 Summary and recommendations; Acknowledgements; and International Infrared Reference Spectra; condoms for purchase by United Nations agencies; intrauterine devices for purchase by United Nations agencies; Guidelines on active pharmaceutical ingredient mas
330   $aThe Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for medicines' quality assurance. Standards are developed by the Committee through worldwide consultation and an international consensus building process. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph.Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial, antitubercul
410  0$aTechnical report series (World Health Organization) ;$v948.
606   $aDrugs$xStandards
606   $aPharmaceutical technology$xStandards
606   $aDrugs$xLaw and legislation
608   $aElectronic books.
615  0$aDrugs$xStandards.
615  0$aPharmaceutical technology$xStandards.
615  0$aDrugs$xLaw and legislation.
676   $a615.1
676   $a615/.1
712 02$aWorld Health Organization.
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910454491403321
996   $aWHO Expert Committee on Specification for Pharmaceutical Preparations$91974787
997   $aUNINA