LEADER 05624nam 2200661 450 001 9910809943303321 005 20230803203700.0 010 $a92-4-069254-1 035 $a(CKB)3710000000198672 035 $a(EBL)1741838 035 $a(SSID)ssj0001416338 035 $a(PQKBManifestationID)11800221 035 $a(PQKBTitleCode)TC0001416338 035 $a(PQKBWorkID)11356665 035 $a(PQKB)10469080 035 $a(MiAaPQ)EBC1741838 035 $a(Au-PeEL)EBL1741838 035 $a(CaPaEBR)ebr10931292 035 $a(OCoLC)897446262 035 $a(EXLCZ)993710000000198672 100 $a20140926h20142014 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aWHO Expert Committee on Specifications for Pharmaceutical Preparations $eforty-eighth meeting report /$fWorld Health Organization 210 1$aGeneva, Switzerland :$cWorld Health Organization,$d2014. 210 4$dİ2014 215 $a1 online resource (401 p.) 225 1 $aWHO Technical Report Series ;$v986 300 $aDescription based upon print version of record. 311 $a92-4-120986-0 327 $aCover; Contents; WHO Expert Committee on Specifications for Pharmaceutical Preparations; 1. Introduction; 2. General policy; 2.1 Cross-cutting pharmaceutical quality assurance issues; 2.1.1 Update from the Expert Committee on the Selection and Use of Essential Medicines; 2.1.2 Update from the Expert Committee on Biological Standardization; 2.1.3 Temperature mapping of a storage area; 2.2 International collaboration; 2.2.1 Collaboration with international organizations and agencies; 2.2.2 Pharmacopoeial Discussion Group 327 $a2.2.3 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)2.2.4 International Conference of Drug Regulatory Authorities; 3. Quality control - specifications and tests; 3.1 The International Pharmacopoeia; 3.1.1 Monographs under elaboration; 3.1.2 Monographs proposed for elaboration or withdrawal from The International Pharmacopoeia; 3.2 Specifications for medicines, including children's medicines; 3.2.1 Maternal, newborn, child and adolescent health medicines; 3.2.2 Antimalarial medicines; 3.2.3 Antiviral medicines 327 $a3.2.4 Antituberculosis medicines3.2.5 Medicines for neglected tropical diseases; 3.2.6 Other anti-infective medicines; 3.2.7 Other medicines; 3.3 General monographs for dosage forms and associated method texts; 3.3.1 Supplementary information; 3.3.2 Reagents, test solutions and volumetric solutions; 3.3.3 General policy; 3.3.4 Radiopharmaceuticals; 4. Quality control - International Reference Materials (International Chemical Reference Substances and Infrared Reference Spectra); 4.1 Update on International Chemical Reference Substances; 4.1.1 Overview 327 $a4.1.2 Release procedure for International Chemical Reference Substances4.1.3 Report from the ICRS Board; 4.1.4 Draft chapter on reference substances and reference spectra for the Supplementary information section of The International Pharmacopoeia; 4.1.5 International Chemical Reference Substances - miscellaneous topics; 4.2 Report of the custodian centre for ICRS; 4.2.1 Annual report; 4.2.2 Update on the annual report; 5. Quality control - national laboratories; 5.1 External Quality Assurance Assessment Scheme; 5.1.1 Final report on EQAAS 5.6; 5.1.2 Preliminary report on EQAAS 5.7 327 $a5.1.3 EQAAS Phase 6 proposals5.2 Networking; 5.3 Training materials for quality control laboratories and microbiological laboratories; 6. Quality assurance - good manufacturing practices; 6.1 Updates of WHO good manufacturing practices; 6.2 Update of WHO good manufacturing practices: validation; 6.3 General guidance for inspectors on "hold-time" studies; 6.4 Training materials; 7. Quality assurance - new initiatives; 7.1 International meetings of world pharmacopoeias; 7.2 Good pharmacopoeial practices; 7.3 FIP-WHO technical guidelines; 7.4 Screening technologies for "suspect" medicines 327 $a7.5 Laboratory functions survey regarding testing of spurious/falsely-labelled/falsified/counterfeit medical products 330 $aThe Expert Committee on Specifications for Pharmaceutical Preparations works towards clear independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radioph 410 0$aTechnical report series (World Health Organization) ;$v986. 606 $aDrugs$xSpecifications$vCongresses 606 $aDrugs$xStandards$vCongresses 606 $aPharmaceutical preparations$xStandards$vCongresses 606 $aPharmaceutical technology$xStandards$vCongresses 615 0$aDrugs$xSpecifications 615 0$aDrugs$xStandards 615 0$aPharmaceutical preparations$xStandards 615 0$aPharmaceutical technology$xStandards 676 $a615.1 712 02$aWorld Health Organization. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910809943303321 996 $aWHO Expert Committee on Specifications for Pharmaceutical Preparations$91917970 997 $aUNINA