Audit Trail Review required before Each Batch Release?

The requirements for the Audit Trail and its review are formulated in Annex 11 of the EU GMP Guidelines: 9 Audit Trails: "Consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated "audit trail"). For change or deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed". The reason for the change or deletion of GMP-relevant data should be documented. Audit Trails must be available, convertible into a generally readable form and regularly reviewed.

If one first looks at the information provided by the legal basis of EU-GMP Annex 11 Section 9 Audit Trails, there are no concrete instructions as to when an Audit Trail is to be reviewed. Here, you can only find the specification concerning the regular examination: "Audit Trails must be available, convertible into a generally readable form and checked regularly".

The EU GMP Annex 11 Section 8 "Printouts" is much more concrete: "8.2 - For  records  supporting  batch  release  it  should  be  possible  to  generate  printouts  indicating if any of the data has been changed since the original entry."


This clearly addresses the documentation related to lot release and involves modified data. This can only mean that an Audit Trail check of the data to be seen in connection with the batch release must also be checked before the release.

Although the PIC/S document PI 041 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS doesn't constitute a legal basis, it can be assumed that inspectors worldwide will follow the provisions and requirements of this guidance. Here, it is again confirmed that all Audit Trails to be seen in connection with batch release must also be reviewed before release: "9.4 Audit trails for computerised systems: Critical audit trails related to each operation should be independently reviewed with all other records related to the operation and prior to the review of the completion of the operation, e.g. prior to batch release, so as to ensure that critical data and changes to it are acceptable."


EU GMP Guideline Annex 11

PIC/S PI 041

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