Problem & answerI-09
Incorrect Batch Documentation
Likely causes
- Missing entries
- Incorrect signatures
- Wrong batch number
- Good Documentation Practice not followed
How to fix it
- 1Stop the documentation activity.
- 2Correct records under GDP: single line through the error, initial, date and explain.
- 3Inform QA if the error affects product release.
It is fixed when
Documentation reviewed and approved by QA.
Stop it coming back
- Train operators in Good Documentation Practice.
Did this solve the problem?