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U.S. FDA expectations and experiences when inspecting Indian drug and API manufacturers.
- In: D17 - Good Manufacturing Practices - Expectations for the coming decade (part I) on Thursday, 8 September 2011, 09:00-12:00
- At: Hyderabad (India) (2011)
- 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...
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Last update 4 October 2019