The EMA has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.

EMA’s GMP / Good Distribution Practice (GDP) Inspectors Working Group has developed a set of questions & answers with advice for stakeholders on measures that ensure data integrity and minimize risks at all stages of the data lifecycle in pharmaceutical quality systems. The advice applies to both paper-based and electronic systems. It 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;
• measures to ensure data integrity for activities contracted out to another company.

The document is aligned with existing GMP guidance published by some regulatory authorities participating in the Pharmaceutical Inspection Co-operation Scheme (PIC/S). It should be read in conjunction with national guidance, medicines legislation and the GMP standards published in Eudralex volume 4.