It’s been a long time coming, but we have officially updated the GMP audit checklist from 21 CFR 110 to 21 CFR 117. The most significant difference between the 21 CFR 110 and 21 CFR 117 is that the FDA now expects proactive enforcement of standards versus reactive enforcement. You can compare the changes here.
In October and November, we will be hosting complimentary DFA Member refresher training on Preventing the Most Common GMP & FSMA Non-Conformities. Stay tuned for more information on these courses and save the dates for:
- October 28 – Preventing the Most Common Non-Conformities from DFA GMP Audits
- November 18 – Preventing the Most Common Non-Conformities from DFA FSMA Audits
As we advance, when DFA auditors are onsite, they will be making recommendations for the new checklist. Still, we will not be auditing or scoring against the new checklist until January 1, 2023, when the new audit year begins.