EMA Releases Data Integrity Guidance

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

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 FDA released its own data integrity draft guidance in April 2016, and a string of FDA-issued warning letters for data integrity violations have recently been published on the agency’s website.

Source: EMA