What the inspector wrote
Comparison of manufacturing batch record entries with the electronic logs of the granulator and the cleanroom access system showed that in-process check times recorded for batch 2041 preceded the operator's entry to the suite by 40 minutes and that six entries with different recorded times were made in identical ink with identical handwriting characteristics. The operator confirmed that entries were routinely completed from memory at the end of the shift.
Why it was cited
EU GMP 4.8 requires that records are made at the time each action is taken. Entries made from memory cannot demonstrate that the check was performed when the record says it was, or at all. The inspector's cross-check against equipment and access logs is routine and takes minutes.
This is not a matter of neatness. Once the inspector shows that recorded times are impossible, every entry by that operator, and every batch record on that line, is in question.
What would have prevented it
- Batch records and logbooks kept at the point of use, with the expectation that the entry is made before moving to the next step. Pens available in the room.
- Supervisors checking for contemporaneous recording during the shift, not QA discovering the pattern at review.
- A late entry rule that people are willing to use: mark it as late, give both dates, state the source. Honest late entries are acceptable; disguised ones are not.