WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-first report.

WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-first report.

This report includes the following guidelines of direct relevance to the United Nations Prequalification Programme for Priority Essential Medicines and for quality control laboratories: procedures governing the assessment of pharmaceutical products for procurement by United Nations agencies and for...

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Bibliographic Details
Corporate Authors: WHO Expert Committee on Specifications for Pharmaceutical Preparations, World Health Organization
Format: eBook
Language:English
Published: Geneva : World Health Organization, ©2007.
Series:Technical report series (World Health Organization) ; 943.
Subjects:
Drugs > Standards > Congresses.
Pharmacopoeias > Congresses.
Drugs > Quality control > Congresses.
Drugs > Quality control
Drugs > Standards
Pharmacopoeias
Conference papers and proceedings
Online Access:Click for online access
Table of Contents:
  • Intro
  • CONTENTS
  • 1. Introduction
  • 2. General Policy
  • 2.1 Cross-cutting pharmaceuticals
  • quality assurance issues
  • 2.2 Pharmacopoeial Discussion Group
  • 2.3 International Conference on Harmonisation
  • 2.4 International Conference of Drug Regulatory Authorities
  • 3. Quality control
  • specifications and tests
  • 3.1 The International Pharmacopoeia (4th ed.)
  • 3.2 New monographs for inclusion in The International Pharmacopoeia
  • 3.3 Dissolution test requirements
  • 3.4 Pharmacopoeial monographs on antiretrovirals
  • 3.5 Specifications for antimalarials
  • 3.6 Quality specifications for antituberculosis drugs
  • 3.7 Specifications for other medicines
  • 4. Quality control
  • International Reference Materials
  • 4.1 International Chemical Reference Substances
  • 4.2 Guidelines for chemical reference substances
  • 5. Quality control
  • national laboratories
  • 5.1 External Quality Assurance Assessment Scheme
  • 6. Quality assurance
  • Good Manufacturing Practices
  • 6.1 Biologicals
  • 6.2 Sterile pharmaceutical products
  • 6.3 New guidelines
  • 7. Quality assurance
  • inspection
  • 7.1 Training modules for inspectors
  • 8. Quality assurance
  • distribution and trade related
  • 8.1 Good distribution practices for pharmaceutical products
  • 9. Quality assurance
  • risk analysis
  • 9.1 New approach to inspections and manufacture
  • 10. Quality assurance
  • Stability
  • 11. Prequalification
  • 11.1 Prequalification of priority medicines
  • 11.2 Ongoing quality monitoring of prequalified medicines
  • 11.3 Prequalification of quality control laboratories
  • 11.4 Procedure for prequalification
  • manufacturers of active pharmaceutical ingredients
  • 11.5 Guidance on variations to a prequalified dossier
  • 12. Regulatory guidance
  • 12.1 Medicines for children.
  • 12.2 Revision/update of the guidance on the selection of comparator pharmaceutical products for equivalence assessment
  • 12.3 Proposal to waive in vivo bioequivalence requirements for immediate release, solid oral dosage forms
  • 12.4 WHO Certification scheme
  • 13. Nomenclature and computerized systems
  • 13.1 International Nonproprietary Names (INN) for pharmaceutical substances
  • 13.2 WHO terminology used in quality assurance
  • 14. Miscellaneous
  • 14.1 Index of pharmacopoeias
  • 14.2 Article on the Expert Committee
  • 14.3 Promotional materials on quality
  • 15. Summary and recommendations
  • 15.1 New standards and guidelines adopted and recommended for use
  • 15.2 Activities that should be pursued and progress reported at the next meeting of the Expert Committee
  • 15.3 New areas of work suggested
  • Acknowledgements
  • Annex 1
  • The International Pharmacopoeia
  • related substances tests: dosage form monographs guidance notes
  • Annex 2
  • List of available International Chemical Reference Substances and International Infrared Reference Spectra
  • Annex 3
  • General guidelines for the establishment, maintenance and distribution of chemical reference substances. Revision
  • Annex 4
  • Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
  • Annex 5
  • Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
  • Annex 6
  • Guidance on variations to a prequalified product dossier.

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