21 CFR 211.67 - Equipment Cleaning and Maintenance

What it says

Equipment and utensils must be cleaned, maintained and, as appropriate, sanitised at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product, with written procedures governing cleaning and maintenance schedules.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This is the anchor provision for the entire cleaning validation lifecycle - MACO calculations, worst-case product selection and swab or rinse sampling all exist to demonstrate compliance with this single sentence.
• For shared, multi-product equipment specifically, this provision requires demonstrated evidence that cleaning between products reliably prevents cross-contamination, not just a written cleaning procedure that is followed.
• Cleaning validation is expected to follow its own lifecycle, design, qualification and continued verification, mirroring the same three-stage logic applied to process validation generally.

What FDA inspectors look for

• Whether cleaning validation exists at all for shared equipment used across multiple products, and whether it is based on documented, health-based exposure limits rather than legacy generic thresholds.
• Whether analytical methods used to verify cleaning effectiveness have a limit of quantitation below the calculated acceptance limit.
• Whether a continued verification programme monitors cleaning effectiveness on an ongoing basis, not just at initial validation.

Related regulations