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European Medicines Agency issues draft guidance on data integrity

Jaclyn Jaeger | August 31, 2016

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently released new draft guidance for pharmaceutical companies on how they can maintain data integrity in the process of testing, manufacturing, packaging, distributing, and monitoring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The 44-page PIC/S draft guidance is focused on providing industry with “consolidated, illustrative guidance on risk-based control strategies” that enable data integrity and reliability as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In addition to the draft guidance, EMA developed a set of 23 new...

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