The Resource WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-ninthReport, (electronic resource)

WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-ninthReport, (electronic resource)

Label
WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-ninthReport
Title
WHO Expert Committee on Specifications for Pharmaceutical Preparations
Title remainder
Forty-ninthReport
Creator
Subject
Language
eng
Summary
The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines from their development to their distribution to patients. In the area of quality control the Expert Committee reviewed new and
Cataloging source
EBLCP
Dewey number
616.1002983745
Index
no index present
LC call number
RS1 .W384 2015
Literary form
non fiction
Nature of contents
dictionaries
Label
WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-ninthReport, (electronic resource)
Publication
Note
  • 7.5 FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products
  • Description based upon print version of record
http://library.link/vocab/branchCode
  • net
Contents
  • Cover; Contents; WHO Expert Committee on Specifications for Pharmaceutical Preparations; 1. Introduction; 2. General policy; 2.1 International collaboration; 2.1.1 Collaboration with international organizations and agencies; 2.2 Cross-cutting pharmaceutical quality assurance issues; 3. Quality control -- specifications and tests; 3.1 The International Pharmacopoeia; 3.1.1 Workplan for The International Pharmacopoeia; 3.2 Specifications for medicines, including paediatric medicines and radiopharmaceuticals; 3.2.1 Maternal, newborn, child and adolescent health medicines
  • 3.2.2 Antiviral medicines, including antiretrovirals3.2.3 Antituberculosis medicines; 3.2.4 Medicines for tropical diseases; 3.2.5 Other anti-infective medicines; 3.2.6 Medicines for anaesthesia, pain and palliative care; 3.2.7 Radiopharmaceuticals; 3.3 General monographs for dosage forms and associated method texts; 3.3.1 General monographs; 3.3.2 General policy; 3.3.3 Analytical methods; 3.4 Update on the process for development of monographs; 3.4.1 General; 3.4.2 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 Report of the custodian centre; 4.1.2 Report of the dedicated subgroup; 5. Quality control -- national laboratories; 5.1 External Quality Assurance Assessment Scheme; 5.1.1 Summary report on External Quality Assurance Assessment Scheme Phase 5; 5.2 Training materials for quality control laboratories and microbiological laboratories
  • 5.3 Report on implementation of WHO good practices for pharmaceutical control laboratories6. Quality assurance -- good manufacturing practices; 6.1 Update of WHO good manufacturing practices for biologicals; 6.2 Update of WHO good manufacturing practices: validation; 6.2.1 Proposal for revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; 6.3 General guidance for inspectors on hold-time studies; 6.4 Update of model inspection report
  • 6.5 Update of questions and answers for WHO good manufacturing practices for active pharmaceutical ingredients6.6 Proposal for new guidance on good data management; 6.7 Training materials; 7. Quality assurance -- new initiatives; 7.1 International meetings of world pharmacopoeias; 7.2 Good pharmacopoeial practices; 7.3 Screening technologies for "suspect" spurious/falsely-labelled/falsified/counterfeit medicines; 7.4 Laboratory functions survey regarding testing of spurious/falsely-labelled/falsified/ counterfeit medical products
Control code
ocn912238554
Dimensions
unknown
Extent
1 online resource (224 p.)
Form of item
online
Isbn
9789240693968
http://library.link/vocab/recordID
.b33084051
Specific material designation
remote
System control number
  • (OCoLC)912238554
  • ebl9240693963

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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