Hopefully you’ll never need to know.
FDA’s Office of Regulatory Affairs (ORA) is the lead office for inspections and enforcement issues, including violations like 483s.
Last year’s #1 “483” violation was “procedures not in writing, fully followed” (18%). And 55% of the total 483s issued referred to a failure to follow written instructions, absence of written procedures, and related violations having to do with reporting and procedures, part of 21 CFR 211. GLP/GMP labs must include an audit trail to allow tracing back the final result to the raw data.
The full report is available at:
Overbrook Support follows guidelines with reports that are recorded and reliable.
New for 2015: FDA announced consideration of a new inspection scoring system that would, for the first time – go beyond GMP – as it is really just the minimum, and recognize drug makers that go beyond normal compliance with good manufacturing practices. Six scores would be offered for each aspect of an inspection, including whether a facility meets GMPs, has an adequate quality system and quality culture. See fda news for details.
Of course, changes and uncertainty go hand in hand, and what happens next is anybody’s guess. As Yogi Berra said, “it’s tough to make predictions, especially when you’re talking about the future”. But one thing is certain: you can count on Overbrook Support to perform specific to your needs.
To learn more about Overbrook Support capabilities, as your single point of contact for comprehensive analytical instrumentation services – from maintenance and repair to relocations/moves and IQ/OQ/PQ, contact Richard Halpern, call 855-782-4373 or Reply Now.
Overbrook is a proud member of ASMS, GBMSDG, ACS, I2SL, SOFT.