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55 documents on 2 pages
 
close this section of the libraryGood Manufacturing Practices (GMP)
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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Title: Inspection of API Manufacturing Sites
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2011 Pages: 4
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: America (AMRO)
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Europe (EURO)
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Title: Survey of the quality of antiretroviral medicines circulating in selected African countries
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2007 Pages: 58
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Regions: Africa (AFRO)
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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
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Regions: Africa (AFRO)
Countries: Cameroon; Ethiopia; Ghana; Kenya; Nigeria; United Republic of Tanzania
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1
Subjects: Quality and Safety: Medicines > Quality Assurance
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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
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 02): - Quality Management
Year: 2006 Pages: 19
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 08): Personnel
Year: 2006 Pages: 29
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 09): Premises
Year: 2006 Pages: 45
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 10): Equipment
Year: 2006 Pages: 26
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 11): Materials
Year: 2006 Pages: 25
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 12): Documentation
Year: 2006 Pages: 55
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2
Subjects: Quality and Safety: Medicines > Quality Assurance
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 01): Introduction
Year: 2006 Pages: 8
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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Title: WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 05): The Inspection
Year: 2006 Pages: 35
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
 
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Last updated: May 3, 2013