EMA has released new good manufacturing practice ("GMP") guidance aimed at ensuring the integrity of data generated in the process of testing, manufacturing, packaging, distributing, and monitoring medicines. 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; and
  • Measures to ensure data integrity for activities contracted out to another company.

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