Subjects

On this page readers can obtain a listing of documents under the subject headings. Click on the name of a subject heading to display the sub-headings, or to return to the main subjects. Click on the icon of a sub-heading to obtain the concerned documents. Publications are available in HTML, PDF

, DOC

or XLS

format. Click on the corresponding icon to open the publication. The PDF icon located on the cover page of a publication represents that the publication is available only in PDF format. If the PDF icon is located near the title of the publication it means the document is available in both HTML and PDF formats.


		WHO Home

		WHO Health Systems and Services

		WHO Medicines

		WHO sites

		Medicines Documentation home

		Search

		Titles A-Z

		Subjects

		Keywords

		Series and Periodicals

		Publishers

		Authors A-Z

		Regions

		Countries

		Index

		Sub-collections

		Public sub-collections

WHO Publications - Non WHO Publications - All

English - French - Spanish - Russian

Expand the sub-collections menu.

110 documents on 2 pages

« Previous | All | Details

Show All | Hide All

Quality and Safety: Medicines

Quality Assurance

Title:	Procedure for Prequalification of Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011 Annex 10
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 17
Publishers:	WHO Headquarters in Geneva
Related documents:	Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
Regions:	Global

Title:	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
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2006 Pages: 47
Publishers:	WHO Headquarters in Geneva
Related documents:	Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regions:	Global

Title:	Provisional Guidelines on the Inspection of Pharmaceutical Manufacturers. WHO Technical Report Series 823, 1992, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	1992 Pages: 12
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:	Global

Title:	Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1 [French]
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1997 Pages: 248
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 2, 2nd Updated Edition - Good Manufacturing Practices and Inspection
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2007 Pages: 416
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Quality Control Methods for Herbal Materials
Subjects:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 187
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	The Quality of Antimalarials - A Study in Selected African Countries - EDM Research Series No. 030
Subjects:	Quality and Safety: Medicines > Quality Assurance
Author:	Maponga, Charles; Ondari, Clive
Year:	2003 Pages: 67
Publishers:	WHO Headquarters in Geneva
Regions:	Africa (AFRO)

Title:	A Rapid Quality Risk Assessment Mechanism for Assessing Needed Pharmaceutical Products that Have Not Completed a Stringent Assessment. WHO Prequalification of Medicines Programme - Briefing Paper: 27 April 2012. Expert Review Panel (ERP)
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 13
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Recommendations for Quality Requirements when Artemisinin is Used as a Starting Material in the Production of Antimalarial Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 970, 2012, Annex 6
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2012 Pages: 9
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Reference Substances and Infrared Reference Spectra for Pharmacopoeial Analysis (WHO Technical Report Series, No. 885, 1999: Annex 3)
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > The International Pharmacopoeia
Year:	1999 Pages: 117
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1994 Pages: 59
Publishers:	WHO Headquarters in Geneva
Related documents:	Drug Quality Control Laboratories
Regions:	Africa (AFRO)

Title:	Stability of Essential Drugs in Tropical Climates: Zimbabwe - EDM Research Series No. 013
Subjects:	Quality and Safety: Medicines > Quality Assurance
Author:	Hogerzeil, Hans V; Muchemwa, T; Nazerali, H
Year:	1994 Pages: 86
Publishers:	WHO Headquarters in Geneva
Regions:	Africa (AFRO)
Countries:	Zimbabwe

Title:	Stability of Injectable Oxytocics in Tropical Climates: Results of Field Surveys and Simulation Studies on Ergometrine, Methylergometrine and Oxytocin - EDM Research Series No. 008
Subjects:	Quality and Safety: Medicines > Quality Assurance
Author:	de Groot, A. N. J. A.; Hogerzeil, Hans V; Vree, T. B; Walker, G. J. A
Year:	1993 Pages: 50
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Stability of Oral Oxytocics in Tropical Climates - Results of Simulation Studies on Oral Ergometrine, Oral Methylergometrine, Buccal Oxytocin and Buccal Desamino-Oxytocin - EDM Research Series No. 012
Subjects:	Quality and Safety: Medicines > Quality Assurance
Author:	de Groot, A. N. J. A.; Hogerzeil, Hans V; Vree, T. B; Walker, G. J. A
Year:	1994 Pages: 52
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series, No. 953, 2009 - Annex 2. (With Table 2 - Updated 1 December 2010)
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2009 Pages: 50
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Starting Materials for Pharmaceutical Products: Control and Safe Trade
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1998 Pages: 10
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Supplementary Guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms. WHO Technical Report Series, No. 961, 2011, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 46
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Supplementary Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines. WHO Technical Report Series, No. 937, 2006, Annex 3
Subjects:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Quality Assurance
Year:	2006 Pages: 22
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 937 - Fortieth Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Supplementary Guidelines on Good Manufacturing Practices: Validation. WHO Technical Report Series, No. 937, 2006, Annex 4
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2006 Pages: 72
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 937 - Fortieth Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Survey of the Quality of Anti-tuberculosis Medicines Circulating in Selected Newly Independent States of the Former Soviet Union
Subjects:	Quality and Safety: Medicines > Quality Assurance
Author:	Nathanson, Eva; Polishchuk, Olexandr; Sabartova, Jitka
Year:	2011 Pages: 108
Publishers:	WHO Headquarters in Geneva World Health Organization - Regional Office for Europe (WHO/EURO)
Related documents:	Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa Survey of the quality of antiretroviral medicines circulating in selected African countries
Regions:	Europe (EURO)

Title:	Survey of the quality of antiretroviral medicines circulating in selected African countries
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2007 Pages: 58
Publishers:	WHO Headquarters in Geneva
Related documents:	Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa Survey of the Quality of Anti-tuberculosis Medicines Circulating in Selected Newly Independent States of the Former Soviet Union
Regions:	Africa (AFRO)

Title:	Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 118
Publishers:	WHO Headquarters in Geneva
Related documents:	Survey of the quality of antiretroviral medicines circulating in selected African countries Survey of the Quality of Anti-tuberculosis Medicines Circulating in Selected Newly Independent States of the Former Soviet Union
Regions:	Africa (AFRO)
Countries:	Cameroon; Ethiopia; Ghana; Kenya; Nigeria; United Republic of Tanzania

Title:	WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1
Subjects:	Quality and Safety: Medicines > Quality Assurance
Publishers:	WHO Headquarters in Geneva

Title:	WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2
Subjects:	Quality and Safety: Medicines > Quality Assurance
Publishers:	WHO Headquarters in Geneva

Title:	WHO Drug Information Vol. 23, No. 3, 2009 - Recommended INN List 62 - International Nonproprietary Names for Pharmaceutical Substances
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2009 Pages: 78
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 23, No. 4, 2009 - Proposed International Nonproprietary Names, List 102
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2009 Pages: 97
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 25, No. 2, 2011 - Proposed International Nonproprietary Names, List 105
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 120
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 25, No. 3, 2011 - Recommended International Nonproprietary Names, List 66
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia
Year:	2011 Pages: 122
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 25, No. 4, 2011 - Proposed International Nonproprietary Names, List 106
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 125
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 26, No. 1, 2012 - Recommended International Nonproprietary Names, List 67
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 96
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 26, No. 2, 2012 - Proposed International Nonproprietary Names, List 107
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 139
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 26, No. 3, 2012 - Recommended International Nonproprietary Names, List 68
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 100
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 26, No. 4, 2012 - Proposed International Nonproprietary Names, List 108
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2013 Pages: 135
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 27, No. 1, 2013 - Recommended International Nonproprietary Names, List 69
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Counterfeit Medicines Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2013 Pages: 93
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	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 [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
Year:	1995 Pages: 36
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Quality Assurance
Publishers:	WHO Headquarters in Geneva

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - Quality Assurance of Pharmaceuticals: Meeting a Major Public Health Challenge
Subjects:	Quality and Safety: Medicines > Quality Assurance
Pages:	36
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 961 - Forty-fifth Report (Geneva, 18–22 October 2010)
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 440
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 250
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Good Manufacturing Practices: Water for Pharmaceutical Use. WHO Technical Report Series, No. 970, 2012, Annex 2 Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Regions:	Global

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings [Arabic] [Chinese] [French] [Russian] [Spanish]
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 16
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Good Distribution Practices for Pharmaceutical Products. WHO Technical Report Series, No. 957, 2010, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2011 Pages: 30
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Good Manufacturing Practices for Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 957, 2010, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2010 Pages: 62
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 957 - Forty-fourth Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles. WHO Technical Report Series, No. 961, 2011, Annex 3
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 54
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011, Annex 6
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 24
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Good Manufacturing Practices: Water for Pharmaceutical Use. WHO Technical Report Series, No. 970, 2012, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 23
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/production/en/index.html
Regions:	Global

Title:	WHO Good Practices for Pharmaceutical Microbiology Laboratories. WHO Technical Report Series, No. 961, 2011, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 25
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Good Practices for Pharmaceutical Quality Control Laboratories. WHO Technical Report Series, No. 957, 2010, Annex 1 [French] [Portuguese] [Spanish] [Thai]
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2010 Pages: 49
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues
Subjects:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Quality Assurance
Year:	2007 Pages: 118
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Guidelines for Preparing a Laboratory Information File. WHO Technical Report Series, No. 961, 2011, Annex 13
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 6
Publishers:	WHO Headquarters in Geneva
Related links:	http://apps.who.int/prequal/
Regions:	Global

Title:	WHO Guidelines on Basic Training and Safety in Chiropractic [French] [Spanish]
Subjects:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Quality Assurance
Year:	2005 Pages: 51
Publishers:	WHO Headquarters in Geneva
Related documents:	Benchmarks for Training in Ayurveda Benchmarks for Training in Naturopathy Benchmarks for Training in Nuad Thai Benchmarks for Training in Osteopathy Benchmarks for Training in Traditional Chinese Medicine Benchmarks for Training in Tuina Benchmarks for Training in Unani Medicine Guidelines on Basic Training and Safety in Acupuncture
Regions:	Global


	« Previous 1 2

Last updated: May 3, 2013