Checking the regulations and newsletters available for the pharmaceutical industry, data integrity is still the most prominent topic. Driven by various inspections since 2012/2013 this trend has meanwhile arrived at small and medium sized pharmaceutical companies. As a regulatory requirement data integrity has already been existing for more than 20 years defined in the FDA 21 CFR Part 11, which was only rarely checked to its full extent during inspections. The numerous data falsifications that have taken place in Asia have shaken up the health regulatory bodies in Europe and in the USA to start regular data checks during their routine inspections worldwide.

New quality requirements for pharmaceutical products are usually defined in regulations, which have to be adhered to and which are part of the international and national GxP rules. For data integrity similar detailed requirements are still missing: Starting in 2015 a number of guidelines, led by the British MHRA, were published as draft versions, but to date not finally approved. Unfortunately, it has to be noticed that there were no efforts to harmonize these draft rules. Those many different approaches lead to confusing the pharmaceutical entrepreneur while trying to reach compliance with the rules. Particularly, the process (“how to”) of the review of relevant audit trails is not yet defined clearly.

The EU GMP Annex 11, published in 2011, just requires “audit trails have to be reviewed regularly“, but without any details. To date such a review was only checked rarely by the European health regulatory inspectors. The only source of information are conferences and seminars were inspectors provide their point of view to the public: For the manufacturing of pharmaceutical dosage forms a detailed review of all critical data, prior to the final release, is required for each batch. The costs, i.e. the extra time needed to review such batch data, could be 1-1.5 hours/batch, depending on the complexity of the processes for production and quality control and also on the size of the audit trails.