03410nam 2200565 a 450 991045449140332120200520144314.01-281-74403-4978661174403892-4-068310-0(CKB)1000000000690056(EBL)349986(OCoLC)476167593(MiAaPQ)EBC349986(Au-PeEL)EBL349986(CaPaEBR)ebr10233795(CaONFJC)MIL174403(OCoLC)437213722(EXLCZ)99100000000069005620080903d2008 uy 0engurcn|||||||||WHO Expert Committee on Specification for Pharmaceutical Preparations[electronic resource] forty-second reportGeneva, Switzerland World Health Organization20081 online resource (150 p.)WHO technical report series,0512-3054 ;948Description based upon print version of record.92-4-120948-8 Includes bibliographical references.Preliminaries; 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 ingredients12 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 masThe 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, antituberculTechnical report series (World Health Organization) ;948.DrugsStandardsPharmaceutical technologyStandardsDrugsLaw and legislationElectronic books.DrugsStandards.Pharmaceutical technologyStandards.DrugsLaw and legislation.615.1615/.1World Health Organization.MiAaPQMiAaPQMiAaPQBOOK9910454491403321WHO Expert Committee on Specification for Pharmaceutical Preparations1974787UNINA