Glossary

Cleaning Validation

Documented evidence that an approved cleaning procedure leaves equipment in a condition suitable for processing medicines.

Related sections

EU GMP Annex 15 §§5, 9–10 21 CFR 211.100 21 CFR 211.110

Related terms

Validation2,555 casesCross-Contamination206 casesWorst Case22 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. Cleaning validation cannot be conducted without specific, reproducible cleaning procedures.
    FDA · FDA Warning Letter · 2024-05-14
  2. Your Senior Vice President of Quality stated that your firm has not conducted a cleaning validation to ascertain that your cleaning process for manufacturing your products can…
    FDA · FDA Warning Letter · 2024-08-27
  3. Your quality assurance personnel stated that your firm has not carried out cleaning validation for non-dedicated manufacturing…
    FDA · FDA Warning Letter · 2024-12-17
See 59 findings that mention this term

Source

EU GMP Annex 15, §10 Cleaning Validation and §12 Glossary
← Browse the whole glossary