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45 keyword(s) & 7 documents on 2 pages
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Title:
Description:
quality assurance system
Title:
Drug Quality Control Laboratories
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
1999
Pages:
42
Publishers:
World Health Organization - Regional Office for Africa (WHO/AFRO)
Related documents:
Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Regions:
Africa (AFRO)
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
Publishers:
WHO Headquarters in Geneva
Regions:
Global
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
Publishers:
WHO Headquarters in Geneva
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
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:
Inspection of API Manufacturing Sites
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2011
Pages:
4
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
1994
Pages:
59
Publishers:
WHO Headquarters in Geneva
Related documents:
Drug Quality Control Laboratories
Regions:
Africa (AFRO)
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
1
2
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