What the inspector wrote
Change control CC-25-0112 revised the granulation end point in the batch record for product X. The first batch manufactured with the revised end point was completed on 18 March. The revised batch record was approved on 21 March, operator training was recorded on 25 March and the change control was approved for implementation on 28 March. Three further changes reviewed showed the same pattern.
Why it was cited
Chapter 1 requires approval of planned changes prior to implementation. The record shows the process changed ten days before the change was approved, on a batch record that was not yet approved, by operators who had not been trained on it. Each is a control that failed; together they show the change control system recorded the change rather than controlled it.
Three further examples make it systemic. One inverted sequence is an error; four is the way the site works.
What would have prevented it
- Separate pre-approval from go-live approval, and make go-live approval a QA check that every gating action (document approval, training, qualification, regulatory status) is complete with evidence.
- Make the change control number a mandatory field on the batch record revision and on the training record, so the sequence is visible from any of the three records.
- Trend 'first use before go-live approval' as a metric of the change system and report it to management review.