Risk-based Determination of the Scope and Frequency of Audit Trail Reviews

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 12: Is there a regulatory basis for the risk-based definition of audit trail review intervals and scope?

Pharmaceutical regulations do not prescribe a specific procedure for determining risk. However, it is recommended to apply the ICH Q9 guideline, a new version of which has been available since 2023. It presents a whole range of methods that can be used as desired; The most common method in the pharmaceutical industry is the FMEA method, which provides a numerical value for the estimated risk. Value ranges of 0-10 and 0-5 are most commonly used, with preference given to value ranges of 0-4 or 0-6, where the median is not used exactly for medium risk.
When defining the intervals, it should be taken into account that all batches are initially checked and, if necessary, the observation period can be reduced to a lower frequency after a long period of time (e.g. one year). However, it is possible that such a practice could lead to objections during an inspection by the authorities.

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