Overhauling Compliance and GMPs

April 2, 2003

Jill Wechsler

Jill Wechsler

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2003, Volume 27, Issue 4

FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.