Guidance needed for Audit of external analytical lab and BE center

(Uday Desai) #1

Please Share guideline and list of points to be reviewed for Audit of external analytical lab and BE center.

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(Sunil R. Budhkar) #2

You may refer GLP guidelines specified in Schedule L of the Indian Drugs and Cosmetics Act and Rules as well as ICH GCP guidelines, USFDA 21CFR 310 for conducting BA/ BE studies, and ANVISA Brazil guidelines, EMA Guidelines for conducting BA/BE studies. Plus, refer USFDA and EMA guidelines on Bioanalytical aspects of BA/BE studies. Besides, there are Asean guidelines on BA/BE studies. Based on these please develop your own checklist of conducting audit of BE centre.

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