MHRA Emphasizes Data Integrity Across the Pharmaceutical Lifecycle

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A draft guidance from the agency expands on a 2015 version — one that applied only to GMP — to touch on all phases of development: laboratory, clinical, manufacturing,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. The definitions in the document remain virtually unchanged, yet offer extended insight on inspection requisites.

“In the GxP version we have used examples applicable to more than one regulated area where illustration was important,” said Mark Birse, group manager inspectorate of the Inspection, Enforcement & Standards Division at MHRA.

The scenarios in the document shed light on how manufacturers can set up and implement data integrity systems. For example, the agency recommends that manufacturers design and operate a system with acceptable controls derived from a data integrity risk analysis. Manufacturers also should continually monitor their control systems and document their rationale for various approaches.

MHRA recommends that commercial suppliers implement self-inspection programs to evaluate the effectiveness of their systems in terms of its risk-and-control measures, data integrity and traceability.

For instance, companies should understand how their systems record data, including their capabilities, limitations and vulnerabilities.

The revised draft guidance also clarifies misinterpretations related to GxP, after noting discrepancies found while conducting inspections.

When corrective action is required, the agency expects companies to implement short-term measures to mitigate risks in the interim.

The comment period for the draft guidance ends Oct. 31.

MHRA’s draft document can be found here: — Joya Patel, José Vasquez

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