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8 documents on 1 page
 
close this section of the libraryActive Pharmaceutical Ingredient - API
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Title: Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2008 Pages: 10
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Regions: Global
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Title: 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
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 76
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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: 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
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2006 Pages: 47
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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: 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
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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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Title: WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2003 Pages: 24
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Regions: Global
 

Last updated: May 3, 2013