Series - WHO Expert Committee on Specifications for Pharmaceutical Preparations

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

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63 documents on 2 pages

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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
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:	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
Publishers:	WHO Headquarters in Geneva
Related documents:	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
Regions:	Global

Title:	Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2012 Pages: 29
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html http://www.who.int/childmedicines/en/
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:	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: Water for Pharmaceutical Use. WHO Technical Report Series, No. 970, 2012, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 23
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
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 Good Practices for Pharmaceutical Microbiology Laboratories. WHO Technical Report Series, No. 961, 2011, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 25
Publishers:	WHO Headquarters in Geneva
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

Title:	WHO Guidelines on Good Manufacturing Practices for Blood Establishments. WHO Technical Report Series 961, 2011, Annex 4
Subjects:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 67
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Guidelines on Transfer of Technology in Pharmaceutical Manufacturing. WHO Technical Report Series, No. 961, 2011, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 25
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Joint FIP/WHO Guidelines on Good Pharmacy Practice: Standards for Quality of Pharmacy Services. WHO Technical Report Series, No. 961, 2011, Annex 8
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
Year:	2011 Pages: 14
Publishers:	WHO Headquarters in Geneva
Regions:	Global

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

Title:	WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011, Annex 6
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 24
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	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
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 2
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 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
Regions:	Global

Title:	Procedure for Prequalification of Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011 Annex 10
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 17
Publishers:	WHO Headquarters in Geneva
Related documents:	Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
Regions:	Global

Title:	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
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 12
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 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
Regions:	Global

Title:	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]
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 10
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Good Distribution Practices for Pharmaceutical Products. WHO Technical Report Series, No. 957, 2010, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2011 Pages: 30
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Good Practices for Pharmaceutical Quality Control Laboratories. WHO Technical Report Series, No. 957, 2010, Annex 1 [French] [Portuguese] [Spanish] [Thai]
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2010 Pages: 49
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
Subjects:	Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2010 Pages: 6
Publishers:	WHO Headquarters in Geneva
Related documents:	Procedure for Prequalification of Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011 Annex 10
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 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 Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 953 - Forty-third Report
Year:	2009 Pages: 178
Publishers:	WHO Headquarters in Geneva
Regions:	Global

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
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:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 948 - Forty-second Report
Year:	2008 Pages: 150
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Guidance on Variations to a Prequalified Product Dossier. WHO Technical Report Series, No. 943, 2007 Annex 6
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2007 Pages: 50
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 943 - Forty-first Report
Year:	2007 Pages: 172
Publishers:	WHO Headquarters in Geneva
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:	Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2006 Pages: 23
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report 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
Regions:	Global

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
Publishers:	WHO Headquarters in Geneva
Related documents:	Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
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:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 937 - Fortieth Report
Year:	2006 Pages: 478
Publishers:	WHO Headquarters in Geneva
Related documents:	Supplementary Guidelines on Good Manufacturing Practices: Validation. WHO Technical Report Series, No. 937, 2006, Annex 4 Supplementary Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines. WHO Technical Report Series, No. 937, 2006, Annex 3
Regions:	Global

Title:	Guidelines for Registration of Fixed-dose Combination Medicinal Products. WHO Technical Report Series, No. 929, 2005, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2005 Pages: 49
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 929 - Thirty-ninth Report
Year:	2005 Pages: 153
Publishers:	WHO Headquarters in Geneva
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:	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
Publishers:	WHO Headquarters in Geneva
Related documents:	Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
Regions:	Global

Title:	Guidelines for the Preparation of a Procurement Agency Information File. WHO Technical Report Series, No. 917, 2003, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2003 Pages: 4
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Procedure for Assessing the Acceptability, in Principle, of Procurement Agencies for Use by United Nations Agencies. WHO Technical Report Series, No. 917, 2003, Annex 6
Subjects:	Medicine Access and Rational Use > Supply Management 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. 917 - Thirty-eighth Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Regions:	Global

Title:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 917 - Thirty-eighth Report
Year:	2003 Pages: 129
Publishers:	WHO Headquarters in Geneva
Related documents:	Procedure for Assessing the Acceptability, in Principle, of Procurement Agencies for Use by United Nations Agencies. WHO Technical Report Series, No. 917, 2003, Annex 6
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:	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:	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:	Guide to Good Storage Practices for Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 9
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Year:	2003 Pages: 12
Publishers:	WHO Headquarters in Geneva
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:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
Year:	2003 Pages: 148
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2002 Pages: 4
Publishers:	WHO Headquarters in Geneva
Related documents:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
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


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Last updated: May 3, 2013