What the inspector wrote
A temperature excursion in cold store CS-02 was recorded as a deviation against batch 4471 only. Twelve other batches of four products were stored in CS-02 during the excursion window. No assessment of impact on these batches was performed and two of them were subsequently certified and distributed.
Cited against EU GMP Chapter 1, 1.4(xiv); Chapter 8, 8.16
Why it was cited
A deviation is an event, not a batch attribute. The inspector's first question after reading any deviation is 'what else was there?' If the report cannot answer it, the finding writes itself, and if any of the other batches has been released the finding escalates.
This failure is usually procedural: the deviation form has one batch number field, so one batch number gets assessed.
What would have prevented it
- Make 'other batches, products, materials and equipment potentially affected' a mandatory section of the impact assessment, with 'none' requiring a justification.
- Give investigators access to the warehouse, equipment and room logs needed to answer the question, and expect them to attach the evidence.
- QA review should refuse to close a deviation whose scope is a single batch number without a documented scoping rationale.
Written from the deficiency categories published by EU and UK regulators. Details are illustrative and do not describe a specific named site.