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WHO Expert Committee on Specifications for Pharmaceutical Preparations

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63 documents en 4 pages

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Titre:	Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2012 Pages: 29
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

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

Titre:	Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Sujets:	Quality and Safety: Medicines > Quality Assurance
An:	2012 Pages: 29
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html http://www.who.int/childmedicines/en/
Régions:	Global

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

Titre:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Sujets:	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
An:	2012 Pages: 250
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	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
Régions:	Global

Titre:	WHO Good Manufacturing Practices: Water for Pharmaceutical Use. WHO Technical Report Series, No. 970, 2012, Annex 2
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2012 Pages: 23
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Régions:	Global

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

Titre:	WHO Good Practices for Pharmaceutical Microbiology Laboratories. WHO Technical Report Series, No. 961, 2011, Annex 2
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 25
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles. WHO Technical Report Series, No. 961, 2011, Annex 3
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 54
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	WHO Guidelines on Good Manufacturing Practices for Blood Establishments. WHO Technical Report Series 961, 2011, Annex 4
Sujets:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
An:	2011 Pages: 67
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	WHO Guidelines on Transfer of Technology in Pharmaceutical Manufacturing. WHO Technical Report Series, No. 961, 2011, Annex 7
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 25
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Joint FIP/WHO Guidelines on Good Pharmacy Practice: Standards for Quality of Pharmacy Services. WHO Technical Report Series, No. 961, 2011, Annex 8
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
An:	2011 Pages: 14
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	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
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 46
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	Model Guidance for the Storage and Transport of Time and Temperature-sensitive Pharmaceutical Products. WHO Technical Report Series, No.961, 2011, Annex 9
Sujets:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
An:	2011 Pages: 49
Éditeurs:	WHO Headquarters in Geneva
Liens associés:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Régions:	Global

Titre:	WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011, Annex 6
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 24
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	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
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 2
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 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
Régions:	Global

Titre:	Procedure for Prequalification of Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011 Annex 10
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 17
Éditeurs:	WHO Headquarters in Geneva
Documents similaires:	Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
Régions:	Global

Titre:	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
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 12
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 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
Régions:	Global

Titre:	Prequalification of Quality Control Laboratories. Procedure for Assessing the Acceptability, in Principle, of Quality Control Laboratories for Use by United Nations Agencies. WHO Technical Report Series, No. 961, 2011, Annex 12 [French]
Sujets:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
An:	2011 Pages: 10
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global

Titre:	WHO Good Distribution Practices for Pharmaceutical Products. WHO Technical Report Series, No. 957, 2010, Annex 5
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
An:	2011 Pages: 30
Éditeurs:	WHO Headquarters in Geneva
Régions:	Global


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Dernière mise à jour: le 3 mai 2013