The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently released new draft guidance for pharmaceutical companies on how they can maintain data integrity in the process of testing, manufacturing, packaging, distributing, and monitoring medicines.

Regulators rely on such data to evaluate the quality, safety, and efficacy of medicines and to monitor their benefit-risk profile throughout the lifecycle of the product.  

The 44-page PIC/S draft guidance is focused on providing industry with “consolidated, illustrative guidance on risk-based control strategies” that enable data integrity and reliability as described in PIC/S guides for Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP).

In addition to the draft guidance, EMA developed a set of 23 new questions and answers on data integrity, which were developed by EMA’s GMP/GDP Inspectors Working Group. The Q&A contains advice for stakeholders on measures that ensure data integrity and minimise risks at all stages of the data lifecycle in pharmaceutical quality systems. The advice applies to both paper-based and electronic systems.

The Q&A specifically addresses:

Assessment of risks to data integrity in the collection, processing and storage of data;

Risk management measures at various stages of the ‘data lifecycle;’

Design and control of both electronic and paper-based documentation systems; and

Measures to ensure data integrity for activities contracted out to another company.

The draft guidance and Q&A aligns with similar draft guidance on data integrity in GMP manufacturing issued in April by the U.S. Food and Drug Administration, which Compliance Week previously reported on here. The FDA is one of many regulatory authorities participating in the PIC/S.

According to EMA, the draft guidance and Q&A should be read in conjunction with national guidance, medicines legislation, and the GMP standards published in Eudralex Volume 4.

Further coverage on the data integrity draft guidance and Q&A will follow in the Sept. 7 edition of Compliance Week. Additionally, to learn more on this and other topics in European compliance, don’t miss the CW Europe conference, this Nov. 7-8, in Brussels, Belgium. Register today!

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