Regulation
US Food and Drug Administration
Published by US Department of Health and Human Services
Regulates medicines supplied to the US through 21 CFR and guidance documents, enforced by inspections.
Why it matters to you: FDA findings on investigations and data integrity shape micro labs worldwide.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| 21 CFR 211.113 | Control of microbiological contamination | Validation of aseptic and sterilisation processes |
| 21 CFR 211.192 | Production record review and investigations | Thorough investigation of failures |
| 21 CFR Part 11 | Electronic records and signatures | Audit trails, unique users |
| Guidance (2004) | Sterile drug products produced by aseptic processing | Personnel, EM, media fills, sterility |
| Guidance | Investigating OOS test results | Phases, retesting, invalidation |
| Guidance (2018) | Data integrity and compliance with CGMP | Shared logins, deleted data, audit trails |
Practical tips
- Form 483 lists observations; a warning letter follows if responses are inadequate.
- Invalidating results without evidence is a common warning letter theme.
Learn and test yourself
Other standards
Summarised in our own words for learning. Always refer to the current official text for exact requirements. How we use references