Pharmaceutical vendors approval manual : a comprehensive quality manual for API and packaging material approval / Erfan Syed Asif.
2021
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Details
Title
Pharmaceutical vendors approval manual : a comprehensive quality manual for API and packaging material approval / Erfan Syed Asif.
Author
Asif, Erfan Syed, author.
Edition
1st.
ISBN
9781000510027 (electronic book)
1000510026
9781032030883
9781000510003 (electronic book)
100051000X
9781003189145 (electronic book)
1003189148
1032030887
1000510026
9781032030883
9781000510003 (electronic book)
100051000X
9781003189145 (electronic book)
1003189148
1032030887
Published
Boca Raton : CRC Press, 2021.
Language
English
Description
1 online resource : illustrations (black and white)
Item Number
10.1201/9781003189145 doi
Dewey Decimal Classification
615.19
Note
1. Finding and Partnering Active Pharmaceutical Ingredients Vendor. 2. Selection of API Vendors and the impacts on Drug products. 3. Approach, Team formation and Planning. 4. Site Standard Operating Procedure for vendors approval. 5 Vendors evaluation records list. 6. Vendors Document check list. 7. Declaration and Quality Commitment. 8. Self-evaluation Questionnaire. 9. Self Evaluation Questionnaire Sterile Bulk Mfg. 10. Quality Agreement. 11. Covering letter for Supplier. 12. Quality Agreement for Generic APIs. Chapter 13. API Audit checklist TOC. 14. Audit report. 15. Cell lines Vendors Selection for Biological products. 16. Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Access Note
Access limited to authorized users
Reproduction
Electronic reproduction. Ann Arbor, MI Available via World Wide Web.
Source of Description
Description based on CIP data; resource not viewed.
Added Corporate Author
ProQuest (Firm)
Available in Other Form
Print version : 9781032030883
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