一个印度孟的客户要了一公斤医药中间体的样品，货值也不多，要这么多东西，有经验的过来说说，都是些什么呀，
checklist for vendor approval documents.
1) vendor questionnaire (format attached)
2) 3 batch samples of 100 gm each with coa
3) method of analysis in detail
4) msds
5) route of synthesis with solvents, reagents & catalysts used in each step.
6) organization chart
7) factory & r & d equipment list
8) patent non infringing statement (format attached)
9) tse - bse certificate (format attached)
10) specification
11) flow chart
12) list of raw material used
13) if class i solvents is used its analysis
14) if any metal catalyst is used its analysis.
15) melamine statement (format attached)
16) genotoxic impurity statement
17) allergens statement (format attached)
18) gmo statement (format attached)
19) residual solvents statement (format attached)
20) cgmp certificate for the intermediate.
21) willingness to be inspected by regulatory authority
22) to provide technical support including documents (filled mbr, ros, brief mfg. process, list of raw materials, process flow, specification & testing method, process validation, stability data), ref. std. & impurity standards etc.
23)willingness to notify changes & deviations related to material to be supplied to ***.
kindly send the above docs (except vendor questionnaire & tse bse) on your letterhead with duly stamped and signed by qa dept only
看晕了我！！！[收起]
