Dear Forum,
What systems are in place to maintain facility regulatory requirements?
Changes and re-interpretation of Part 11 is a good example for changing
company regulatory stature. Should systems be reviewed periodically as
part of re-qualification? Interpretation of cGMPs seem best discovered
through education, networking, and reference manuals from ISPE or PDA.
How are these changes best implemented and/or communicated through company
organizations?
Thank you for your thoughts and comments.
Gary Campbell
Gcampbell@Watsonpharm.com
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