Content Review of the Audit Trail Review

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 are described in much greater detail than before. Six 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 15: Which person with which role usually performs the double-checking, i.e. the content review of the audit trail review that has been carried out?

The audit trail review is a review of the changes/additions/deletions made after the initial entry of the data. It is not necessary for another person to check the review that has already been carried out. The content of the audit trail must be checked in every case, i.e. the reviewer must have in-depth knowledge of the respective process. A purely formal Audit Trail Review is not permitted. To clarify: only one person with expertise is required to carry out the ATR.

Question 16: Does QA not also come into play during the review? As a check that the review has been carried out?

As part of its regular self-inspections, the quality assurance department should check that the audit trails of all manufactured batches have been examined for deviations/changes in a review.

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