EMA Releases Data Integrity Guidance

On August 11, 2016, the European Medicines Agency (EMA) announced the publication of a new GMP data integrity guidance. Data from testing, manufacturing, packaging, distribution, and monitoring of drugs is used by regulators to review the quality, safety, and efficacy of drugs; therefore, ensuring the integrity and completeness of such data is important.

The EMA guidance includes a set of questions and answers developed by the agency’s GMP/Good Distribution Practice Inspectors Working Group. The document addresses the assessment of risk to data integrity, risk-management strategies, design and control of electronic and paper-based documentation systems, and ensuring data integrity of outside contractors.

EMA stated in a press release that the new guidance is aligned with other guidance issued by regulatory authorities participating in the Pharmaceutical Inspection Co-operation Scheme (PIC/S). It appears that regulators are taking a closer look at data integrity industry wide. FDA released its own data integrity draft guidance in April 2016, and a string of FDA-issued warning letters for data integrity violations have recently been published on the agency’s website.