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Title:
Description:
quality assurance
Title:
Comité de Expertos de la OMS en Especificaciones para las Preparaciones Farmacéuticas: Resultados de las 44 Reuniones
[
Arabic
] [
Chinese
] [
English
] [
French
] [
Russian
]
Subjects:
Calidad y seguridad de los medicamentos
>
Garantía de calidad
Year:
2011
Pages:
16
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
Comité OMS d'experts des spécifications relatives aux préparations phramaceutiques: Bilan de 44 réunions
[
Arabic
] [
Chinese
] [
English
] [
Russian
] [
Spanish
]
Subjects:
Qualité et innocuité des médicaments
>
Assurance de la qualité
Year:
2011
Pages:
16
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:
A Definição de Medicamentos Prioritários para o Monitoramento da Qualidade Laboratorial no Brasil: Articulação entre a Vigilância Sanitária e a Política Nacional de Medicamentos (The Definition of Priority Medicines for Monitoring Laboratory Quality in Brazil: The Interface between Health Surveillance and the National Drug Policy)
Author:
MASSENA, Elisa Prestes
;
MIRANDA, Maria Do Carmo
;
Osorio-de-Castro, Claudia Garcia Serpa
;
PEPE, Vera Lucia Edais
;
PONTES JUNIOR, Durval Martins
;
PORTELA, Margareth Crisóstomo
;
SILVA, Raulino Sabino da
Year:
2008
Pages:
10
Publishers:
PAHO/WHO Collaborating Center for Pharmaceutical Policies - National School of Public Health - Oswaldo Cruz Foundation
Countries:
Brazil
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:
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:
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 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:
Guidance for Inspection of Drug Distribution Channels. WHO Technical Report Series, No. 885, 1999, Annex 6
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Year:
1999
Pages:
21
Publishers:
WHO Headquarters in Geneva
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:
Global
Title:
Guidance on Good Manufacturing Practices (GMP): Inspection Report. WHO Technical Report Series, No. 908, 2003, Annex 6
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2003
Pages:
5
Publishers:
WHO Headquarters in Geneva
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:
Global
Title:
Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, 19-23 October 2009
[
Portuguese
] [
Spanish
]
Subjects:
Quality and Safety: Medicines
>
Blood Products and Related Biologicals
Quality and Safety: Medicines
>
Quality Assurance
Year:
2009
Pages:
34
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
Guidelines on Good Manufacturing Practices for Radiopharmaceutical Products. WHO Technical Report Series, No. 908, 2003, Annex 3
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2003
Pages:
10
Publishers:
WHO Headquarters in Geneva
Related documents:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:
Global
Title:
Guidelines on Packaging for Pharmaceutical Products. WHO Technical Report Series, No. 902, 2002, Annex 9
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2002
Pages:
38
Publishers:
WHO Headquarters in Geneva
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regions:
Global
Title:
Handbook: Good Laboratory Practice (GLP). Quality Practices for Regulated Non-clinical Research and Development - 2nd Ed.
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2009
Pages:
328
Publishers:
WHO/TDR - World Health Organization Special Programme for Research and Training in Tropical Diseases
WHO Headquarters in Geneva
The World Bank (WB)
United Nations Children's Fund (UNICEF)
United Nations Development Programme (UNDP)
Related documents:
Handbook: Non-Clinical Safety Testing
Regions:
Global
Title:
Inspection of API Manufacturing Sites
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2011
Pages:
4
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
Malaria Microscopy Quality Assurance Manual. Version 1
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2009
Pages:
149
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2002
Pages:
4
Publishers:
WHO Headquarters in Geneva
Related documents:
Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Regions:
Global
Title:
Model Certificate of Good Manufacturing Practices. WHO Technical Report Series, No. 908, 2003, Annex 5
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2003
Pages:
4
Publishers:
WHO Headquarters in Geneva
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:
Global
Title:
A Model Quality Assurance System for Procurement Agencies - Recommendations for Quality Assurance Systems Focusing on Prequalification of Products and Manufacturers, Purchasing, Storage and Distribution of Pharmaceutical Products
[
French
]
Subjects:
Medicine Access and Rational Use
>
Supply Management
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2007
Pages:
140
Publishers:
WHO Headquarters in Geneva
Regions:
Global
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:
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:
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:
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:
Règles OMS de bonnes pratiques applicables par les laboratoires de contrôle qualité pharmaceutique. OMS, Série de Rapports techniques, N° 957, 2010, Annexe 1
[
English
] [
Portuguese
] [
Spanish
] [
Thai
]
Subjects:
Qualité et innocuité des médicaments
>
Assurance de la qualité
Préqualification des médicaments
>
Projet OMS-UNICEF-ONU
Year:
2010
Pages:
38
Publishers:
WHO Headquarters in Geneva
Related links:
http://apps.who.int/prequal/
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:
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:
WHA 65.19 Produits médicaux de qualité inférieure/faux/ faussement étiquetés/falsifiés/contrefaits. 26 mai 2012
[
English
] [
Spanish
]
Subjects:
Qualité et innocuité des médicaments
>
Médicaments contrefaits
Year:
2012
Pages:
5
Publishers:
WHO Headquarters in Geneva
Related links:
http://apps.who.int/gb/or/f/
Regions:
Global
Title:
WHA65.19 Substandard/spurious/falsely-labelled/falsified/counterfeit medical products. 26 May 2012
[
French
] [
Spanish
]
Subjects:
Quality and Safety: Medicines
>
Counterfeit Medicines
Year:
2012
Pages:
5
Publishers:
WHO Headquarters in Geneva
Related links:
http://apps.who.int/gb/or/
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. 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. 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 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. 957 - Forty-fourth Report
Subjects:
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2010
Pages:
292
Publishers:
WHO Headquarters in Geneva
Related documents:
WHO Good Manufacturing Practices for Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 957, 2010, Annex 2
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 Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings (Arabic Version)
[
Chinese
] [
English
] [
French
] [
Russian
] [
Spanish
]
Year:
2011
Pages:
16
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings (Chinese Version)
[
Arabic
] [
English
] [
French
] [
Russian
] [
Spanish
]
Year:
2011
Pages:
16
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Outcome of 44 Meetings (Russian Version)
[
Arabic
] [
Chinese
] [
English
] [
French
] [
Spanish
]
Subjects:
Качество и безопасность лекарственных средств
>
Обеспечение качества
Year:
2011
Pages:
16
Publishers:
WHO Headquarters in Geneva
Regions:
Global
1
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