US FDA
21 CFR 211.113 - Control of Microbiological Contamination
Plain-language explanation, inspection context and common violation patterns.
What it says
Appropriate written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile must be established and followed, and for drug products purporting to be sterile, written procedures designed to prevent microbiological contamination must include validation of sterilisation processes.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- This provision applies in two distinct tiers: non-sterile products must control against objectionable organisms specifically relevant to the product's route of administration and patient population, while sterile products carry the much higher bar of validated sterility assurance.
- What counts as an objectionable organism is product and route-specific - an organism that is a serious concern for an ophthalmic or inhaled product may be a lower concern for certain oral solid products.
- For sterile products, this provision is the anchor requiring validated sterilisation processes, environmental monitoring and aseptic process simulation to work together as a connected system.
What FDA inspectors look for
- Whether a documented, product-specific rationale exists for which organisms are considered objectionable for that product and route of administration.
- For sterile products, whether environmental monitoring, aseptic process simulation and sterilisation validation are treated as one integrated contamination control system rather than separate, disconnected programmes.
- Whether excursions or trends in microbiological data are investigated with the same rigor as any other GMP deviation.
Most common violation
Non-sterile product microbial limits set generically rather than based on a documented, route-specific objectionable organism assessment, and for sterile products, environmental monitoring or sterilisation validation gaps that are treated as isolated laboratory findings rather than contamination control system failures.
Want a deeper, interactive breakdown?
GMPify's Regulation Explainer tool gives subscribers an AI-powered analysis of any 21 CFR, EU GMP, USP or ICH reference, with live inspection context.
Try the Regulation Explainer →