MHRA Emphasizes Data Integrity Through Pharmaceutical Lifecycle

August 3, 2016

MHRA is expanding its data integrity expectations across all stages of the pharmaceutical lifecycle.

A draft guidance from the agency expands on a 2015 version — one that applied only to GMP — to touch on all phases of development: laboratory, clinical, manufacturing, distribution and pharmacovigilance. Through real-world scenarios and practical definitions, MHRA shows how these data integrity principles apply to GxP.

The document broadens the reach of existing definitions in the guidance to cover the entirety of GxP, while sprinkling in a few scenarios that sprung up during inspections for clarification.

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