U.S. FDA expectations and experiences when inspecting Indian drug and API manufacturers.
- At: 2011 FIP Congress in Hyderabad (India)
- Type: Presentation
- By: ROSS, Bruce (U.S. Food and Drug Administration, Delhi, India)
This talk will cover some of the expectations for a pharmaceutical GMP or pre-approval inspection conducted by the U.S. Food and Drug Administration, covering common citations and issues identified Â while providing the audience with some solutions and areas that improvements might be made at the firm to reduce findings or a 483-issuance...
Presenting The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.