Presentation · March 2025
What are FDA's GMP Expectations
Ileana Barreto-Pettit, R.N., M.P.H. · Former FDA National Drug Expert
Parexel · Speaker
48th International GMP Conference, University of Georgia, Athens, GA
"Can this be cited on an FDA-483?" The purpose of cGMPs under 21 CFR 210 and 211 is to produce safe and effective drugs that meet quality standards. FDA expectations are not consolidated in a single source for every situation, so this presentation identifies where they are documented and how a firm defends its actions.
The presentation reviews the cGMP preamble in the Federal Register, FDA Compliance Programs, current guidance documents, and the agency's procedural manuals. It then examines how investigators build a case, illustrated with FDA-483 observations and Warning Letters.
Where to Find FDA's Expectations
- The preamble to the cGMP regulations in the Federal Register
- FDA Compliance Programs, such as CP 7356.002 Drug Manufacturing Inspections
- Guidance documents (most current, not withdrawn)
- Compliance Policy Guides (CPG), the Regulatory Procedures Manual (RPM), and Field Management Directives (FMD)
Can This Be Cited on an FDA-483?
- FDA needs to understand your scientific rationale for your practices
- Is your practice compliant with 21 CFR 210 & 211 requirements? "shall" vs "should"
- Can you defend your actions to ensure product quality standards are consistently met?
- If it is not documented, it didn't happen
- In investigations, human error is a red flag to FDA
Key Takeaways
- Understand and follow the regulations, 21 CFR 210 & 211
- Continuous and focused training of all employees
- Establish a mature quality culture and quality oversight
- Identify and manage all potential risks (ICH Q9 · Quality Risk Management)
- Continuous improvement: identify, correct, document, and learn from deviations holistically
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