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Quality Assurance of Medicines

READINGS

Quality Assurance of Medicines

• Quality Assurance Web Page

• Quality Assurance of Pharmaceuticals.
  A Compendium of Guidelines and Related Materials. Volume 1
• (F)

• Quality Assurance of Pharmaceuticals.
  A Compendium of Guidelines and Related Materials.
  Volume 2 - 2nd Updated and Revised Edition - Good Manufacturing Practices and Inspection

• The International Pharmacopoeia, Fourth Edition 2008

• Basic Tests for Drugs.
  Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms
• (F)
• (S)

• Basic Tests for Pharmaceutical Dosage Forms
• (F)
• (S)

• Basic Tests for Pharmaceutical Substances
• (F)
• (S)

• Drug Regulation: History, Present and Future.
  In: van Boxtel CJ, Santoso B, Edwards IR eds., Drug Benefits and Risks:
  International Textbook of Clinical Pharmacology, revised 2nd ed. (Chapter 6).
  IOS Press and Uppsala Monitoring Centre, 2008
  pdf, 129kb

• Quality Control Methods for Medicinal Plant Materials

• The Quality of Antimalarials. A Study in Selected African Countries
  EDM Research Series N° 30

• Survey of the Quality of Antiretroviral Medicines Circulating in Selected African Countries
  (September 2007)
  pdf, 2.40Mb

• Counterfeit Drugs.
  Guidelines for the Development of Measures to Combat Counterfeit Drugs
• (F)
• (S)

WHO Expert Committee on the Specifications for Pharmaceutical Preparations

• Quality Assurance of Pharmaceuticals: Meeting a Major Public Health Challenge
  pdf, 661kb

• Specifications for Pharmaceutical Preparations

• 44th Report of the WHO Expert Committee. WHO Technical Report Series 957, 2010
  pdf, 874kb

• 43th Report of the WHO Expert Committee. WHO Technical Report Series 953, 2009
  pdf, 999kb

• 42nd Report of the WHO Expert Committee. WHO Technical Report Series 948, 2008
  pdf, 593kb

PRESENTATIONS

• Medicines regulation: Introduction
  ppt, 2.00Mb

• Safe quality medicines.
  Medicines quality assurance: WHO normative functions in the field of pharmaceuticals
  ppt, 5.54Mb