Problem & answerI-02
Cleaning Verification Failure
Likely causes
- Poor cleaning
- Residual product
- Incorrect cleaning chemicals
- Inadequate rinsing
How to fix it
- 1Stop production.
- 2Repeat the complete clean.
- 3Repeat ATP swab or visual inspection.
- 4Investigate the root cause; raise a CAPA if required.
- 5Obtain QA approval before restart.
It is fixed when
Cleaning verification passes to SOP.
Stop it coming back
- Train operators and verify cleaning after every batch.
Did this solve the problem?