Title:
WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-eighth Meeting Report.
Technical Report Series
Technical report series.
Main Entry:
Organization, World Health.
Publisher:
World Health Organization,
Publication Date:
2014.
Publication Place:
Geneva :
ISBN:
9789240692541
9240692541
Subject:
Drugs -- Specifications -- Congresses.
Drugs -- Standards -- Congresses.
Pharmaceutical preparations -- Standards -- Congresses.
Technology, Pharmaceutical -- Standards -- Congresses.
Electronic books.
Series:
Technical Report Series
Technical report series.
Contents:
Cover; 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
2.2.3 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
3.2.4 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
4.1.2 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
5.1.3 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
Related Records:
Print version: Organization, World Health WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-eighth Meeting Report Geneva : World Health Organization,c2014 9789241209861
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