TY  - GEN
T1  - Pharmaceutical vendors approval manual :a comprehensive quality manual for API and packaging material approval /
AU  - Asif, Erfan Syed,
ET  - 1st.
N1  - 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.
ID  - 1390310
KW  - Drugs
KW  - Drugs
KW  - Drugs
KW  - Drugs
KW  - Pharmaceutical industry
KW  - Pharmaceutical industry
SN  - 9781000510027
SN  - 1000510026
SN  - 9781000510003
SN  - 100051000X
SN  - 9781003189145
SN  - 1003189148
TI  - Pharmaceutical vendors approval manual :a comprehensive quality manual for API and packaging material approval /
LK  - https://univsouthin.idm.oclc.org/login?url=https://ebookcentral.proquest.com/lib/usiricelib-ebooks/detail.action?docID=6803791
UR  - https://univsouthin.idm.oclc.org/login?url=https://ebookcentral.proquest.com/lib/usiricelib-ebooks/detail.action?docID=6803791
ER  -