Events in an Audit Trail and Determination of GMP-Relevant Data in the Audit Trail

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 4: Which events must be recorded in the audit trail? Only GMP-relevant operator entries or also technical malfunctions of important components?

The audit trail should log all quality-critical data changes and operator interventions. Critical alarms and warnings that are acknowledged by the user and, if necessary, resolved with a parameter change in the system must therefore also be logged. Pure notifications that are resolved by the system or device itself without user intervention belong in the alarm or deviation list and, if necessary, in the batch or examination report.

Question 5: Who determines the results relevant to the audit trail? The customer, the supplier, or both?

Both. Based on their knowledge of the system, the supplier can only specify the critical points known to them (in analytics, this is usually sufficient). For process-relevant points (e.g. in a process control system), the customer must check whether all relevant points of their manufacturing process have been sufficiently taken into account by the supplier and, if necessary, have the parameterisation changed.

 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