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110 documents on 6 pages

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Quality and Safety: Medicines

Quality Assurance

Title:	13th International Conference of Drug Regulatory Authorities (ICDRA) Berne, Switzerland, 16-19 September 2008. ICDRA: Medicines Agencies Decide Future Action
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2008 Pages: 19
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regions:	Global

Title:	14th International Conference of Drug Regulatory Authorities(ICDRA), Singapore 30 November - 3 December 2010
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2011 Pages: 16
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html

Title:	Accelerated Stability Studies of Widely Used Pharmaceutical Substances Under Simulated Tropical Conditions
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1986 Pages: 119
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2006 Pages: 23
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report Proposal to Waive in Vivo Bioequivalence Requirements for WHO Model List of Essential Medicines Immediate-release, Solid Oral Dosage Forms. WHO Technical Report Series, No. 937, 2006, Annex 8
Regions:	Global

Title:	Antimalarial Medicines in Kenya. Availability, Quality and Registration Status. A Baseline Study Undertaken Prior to Nationwide Distribution of Artemether-Lumefantine (AL) in Kenya
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Quality Assurance
Year:	2007 Pages: 41
Publishers:	WHO Country Office in Kenya Kenya Ministry of Health Health Action International - Africa
Regions:	EAC East African Community
Countries:	Kenya

Title:	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2003 Pages: 14
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Basic Tests for Drugs - Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1998 Pages: 100
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Basic Tests for Pharmaceutical Substances [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1986 Pages: 216
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2002 Pages: 4
Publishers:	WHO Headquarters in Geneva
Related documents:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Regions:	Global

Title:	Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2012 Pages: 29
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html http://www.who.int/childmedicines/en/
Regions:	Global

Title:	Drug Quality Control Laboratories
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1999 Pages: 42
Publishers:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Related documents:	Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Regions:	Africa (AFRO)

Title:	Drug Quality Screening in Developing Countries: Establishment of an Appropriate Laboratory in Swaziland
Subjects:	Quality and Safety: Medicines > Quality Assurance
Author:	Kenyon, A.S.; Kenyon, T.A.; Sibiya, T.
Year:	1994 Pages: 6
Publishers:	WHO Headquarters in Geneva
Countries:	Swaziland

Title:	EDM Research Series [French] [Spanish]
Subjects:	Medicine Access and Rational Use > Financing Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Quality Assurance
Publishers:	WHO Headquarters in Geneva

Title:	Ensuring Quality Medicines: A Decade of Prequalification
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Author:	van Zyl, A. J.
Year:	2011 Pages: 9
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Framework for Implementation of Equivalence Requirements for Pharmaceutical Products. PANDRH Technical Report Nº 8, Pan American Network on Drug Regulatory Harmonization
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 38
Publishers:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regions:	Global; America (AMRO)

Title:	Good Manufacturing Practices for Biological Products. In: WHO Expert Committee on Biological Standardization. Forty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822), Annex 1; and WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834), Annex 3
Subjects:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Year:	1992 Pages: 11
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Biological Standardization - WHO Technical Report Series, No. 822 - Forty-second Report WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans. WHO Technical Report, Series No. 863 , 1996, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1996 Pages: 16
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1999 Pages: 22
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Good Practices for Selecting and Procuring Rapid Diagnostic Tests for Malaria
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 109
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Good Procurement Practices for Artemisinin-Based Antimalarial Medicines
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Year:	2010 Pages: 128
Publishers:	WHO Headquarters in Geneva
Regions:	Global


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Last updated: May 3, 2013