Audit Trail Review by the QP / Dealing with a Lack of Justification

The requirements for an audit trail can be found in all relevant regulations. The changes and deletions of data, and in future also the creation of data, should be tracked in this way. In the new draft of the EU GMP Guideline Annex 11, the requirements were described in much greater detail than before. 6 Experts from the pharmaceutical industry and from inspectorates answer an extensive list of questions in this context, focusing on the currently valid Annex 11.

Question 6: Confirmation of the audit trail review takes place on screen. How does the QP check this during batch release, and is it required for release?

Firstly, the audit trail review must be regulated in an SOP. The person conducting the review should be independent of the business process in some way. The review is documented. The review can be part of the batch record review.

Discrepancies in audit trails must be investigated and resolved, including escalation processes for notification, who needs to be informed and when? The QP's assessment of the deviations is decisive for the release of a medicinal product. The product can then be released.

Question 7: Is the absence of a comment (reason for a change) in the audit trail sufficient grounds for a complaint during an inspection?

According to EU GMP Annex 11, the change or deletion must be justified. If the system is capable of doing this and no reason has been entered, this constitutes a deficiency. If the system is not capable of documenting the reason, a corresponding workaround is required. For systems without this functionality, an SOP can be used to regulate how changes or deletions are documented in a logbook.

Find more Q&As on the topic 'Audit Trail' which have been answered by the expert team.

The Expert Team:

Klaus Feuerhelm, Local GMP Inspectorate / Regierungspräsidium Tübingen
Eberhard Kwiatkowski, PharmAdvantageIT, Neuschoo
Dr Ullrich Opitz, Merck, Darmstadt
Yves Samson, Kereon, Basel
Dr Wolfgang Schumacher, ehem. F. Hoffmann-La Roche, Basel
Dr Arno Terhechte, Local GMP Inspectorate / Bezirksregierung Münster