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Title:
Description:
Good Manufacturing Practices (GMP)
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:
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 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 Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2003
Pages:
19
Publishers:
WHO Headquarters in Geneva
Related documents:
WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
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 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:
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:
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:
Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 937, 2006, Annex 7
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Year:
2006
Pages:
44
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:
Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2012
Pages:
29
Publishers:
WHO Headquarters in Geneva
Related documents:
Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
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:
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:
Requisitos armonizados para el registro de vacunas en la Región de las Américas y Guía para la preparación de una solicitud de registro sanitario. Red PARF Documento Técnico No. 1 (Red Panamericana de Armonización de la Reglamentación Farmacéutica), Noviembre de 2008
Subjects:
Calidad y seguridad de los medicamentos
>
Garantía de calidad
Calidad y seguridad de los medicamentos
>
Apoyo en materia de reglamentación
Calidad y seguridad de los medicamentos
>
Seguridad y eficacia
Year:
2010
Pages:
38
Publishers:
World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regions:
America (AMRO)
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) - Basic Principles of GMP: Module 1 (Part 01): Introduction to the Training Course
Year:
2006
Pages:
17
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 02): - Quality Management
Year:
2006
Pages:
19
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 03): Sanitation and Hygiene
Year:
2006
Pages:
30
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 04): Qualification and Validation
Year:
2006
Pages:
28
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 05): Complaints and Recalls
Year:
2006
Pages:
22
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 06): Contract Production and Analysis
Year:
2006
Pages:
14
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 07): Self:inspection and Quality Audits
Year:
2006
Pages:
17
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 08): Personnel
Year:
2006
Pages:
29
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 09): Premises
Year:
2006
Pages:
45
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 10): Equipment
Year:
2006
Pages:
26
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 11): Materials
Year:
2006
Pages:
25
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 12): Documentation
Year:
2006
Pages:
55
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 13): Good Practices in Production and Quality Control
Year:
2006
Pages:
30
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
Year:
2006
Pages:
62
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 15): Active Pharmaceutical Ingredients
Year:
2006
Pages:
23
Publishers:
WHO Headquarters in Geneva
Regions:
Global
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 Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 01): Introduction
Year:
2006
Pages:
8
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 02): The Role of the Inspector
Year:
2006
Pages:
9
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 03): Preparation for the Inspection
Year:
2006
Pages:
12
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 04): Types of GMP Inspection
Year:
2006
Pages:
14
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 05): The Inspection
Year:
2006
Pages:
35
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 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
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