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8 documents en 1 page
 
fermer cette partie de la bibliothèqueActive Pharmaceutical Ingredient - API
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Titre: Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Sujets: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
An: 2008 Pages: 10
Éditeurs:
WHO Headquarters in Geneva
Documents similaires:
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
Régions: Global
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Titre: 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
Sujets: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
An: 2012 Pages: 76
Éditeurs:
WHO Headquarters in Geneva
Documents similaires:
Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Régions: Global
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Titre: Inspection of API Manufacturing Sites
Sujets: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
An: 2011 Pages: 4
Éditeurs:
WHO Headquarters in Geneva
Régions: Global
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Titre: 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
Sujets: Quality and Safety: Medicines > Quality Assurance
An: 2006 Pages: 47
Éditeurs:
WHO Headquarters in Geneva
Documents similaires:
Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Liens associés:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Régions: Global
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Titre: 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
Sujets: Quality and Safety: Medicines > Quality Assurance
An: 2012 Pages: 9
Éditeurs:
WHO Headquarters in Geneva
Régions: Global
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Titre: 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)
Sujets: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
An: 2009 Pages: 50
Éditeurs:
WHO Headquarters in Geneva
Régions: Global
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Titre: WHO Good Manufacturing Practices for Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 957, 2010, Annex 2
Sujets: Quality and Safety: Medicines > Quality Assurance
An: 2010 Pages: 62
Éditeurs:
WHO Headquarters in Geneva
Documents similaires:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 957 - Forty-fourth Report
Liens associés:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Régions: Global
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Titre: WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
Sujets: Quality and Safety: Medicines > Quality Assurance
An: 2003 Pages: 24
Éditeurs:
WHO Headquarters in Geneva
Documents similaires:
Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
Régions: Global
 

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