001390310 000__ 02717nam\a22005531i\4500 001390310 001__ 1390310 001390310 003__ NhCcYBP 001390310 005__ 20220420003052.0 001390310 006__ m\\\\\o\\d\\\\\\\\ 001390310 007__ cr\un\nnnunnun 001390310 008__ 211011s2021\\\\flua\\\\o\\\\\000\0\eng\d 001390310 020__ $$a9781000510027$$q(electronic book) 001390310 020__ $$a1000510026 001390310 020__ $$z9781032030883 001390310 020__ $$a9781000510003$$q(electronic book) 001390310 020__ $$a100051000X 001390310 020__ $$a9781003189145$$q(electronic book) 001390310 020__ $$a1003189148 001390310 020__ $$z1032030887 001390310 0248_ $$a10.1201/9781003189145$$2doi 001390310 040__ $$aNhCcYBP$$cNhCcYBP 001390310 08204 $$a615.19$$223 001390310 1001_ $$aAsif, Erfan Syed,$$eauthor.$$1https://isni.org/isni/0000000077890532. 001390310 24510 $$aPharmaceutical vendors approval manual :$$ba comprehensive quality manual for API and packaging material approval /$$cErfan Syed Asif. 001390310 250__ $$a1st. 001390310 264_1 $$aBoca Raton :$$bCRC Press,$$c2021. 001390310 300__ $$a1 online resource :$$billustrations (black and white) 001390310 336__ $$atext$$2rdacontent 001390310 336__ $$astill image$$2rdacontent 001390310 337__ $$acomputer$$2rdamedia 001390310 338__ $$aonline resource$$2rdacarrier 001390310 500__ $$a1. 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. 001390310 506__ $$aAccess limited to authorized users 001390310 533__ $$aElectronic reproduction.$$bAnn Arbor, MI$$nAvailable via World Wide Web. 001390310 588__ $$aDescription based on CIP data; resource not viewed. 001390310 650_0 $$aDrugs$$xQuality control. 001390310 650_0 $$aDrugs$$xStandards. 001390310 650_0 $$aDrugs$$xPackaging$$xQuality control. 001390310 650_0 $$aDrugs$$xPackaging$$xStandards. 001390310 650_0 $$aPharmaceutical industry$$xQuality control. 001390310 650_0 $$aPharmaceutical industry$$xStandards. 001390310 655_0 $$aElectronic books 001390310 7102_ $$aProQuest (Firm) 001390310 77608 $$iPrint version :$$z9781032030883 001390310 852__ $$bebk 001390310 85640 $$3GOBI DDA$$uhttps://univsouthin.idm.oclc.org/login?url=https://ebookcentral.proquest.com/lib/usiricelib-ebooks/detail.action?docID=6803791$$zOnline Access 001390310 909CO $$ooai:library.usi.edu:1390310$$pGLOBAL_SET 001390310 980__ $$aBIB 001390310 980__ $$aEBOOK 001390310 982__ $$aEbook 001390310 983__ $$aOnline