EMA Clarifies GMP Standards to Preserve Integrity Across Data Lifecycle

The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle.

A Q&A guidance released Thursday clarifies the risk-based strategies industry can take to safeguard data. The document spells out the basics, explaining the purpose of data integrity and defining the purview of the data lifecycle, while also offering drugmakers a slew of points to consider.

Most of the information addressed in the document summarizes existing guidance, although it does provide some new examples for clarity.

The EMA suggests drugmakers start off with a risk assessment that evaluates “the vulnerability of data to involuntary or deliberate amendment, deletion or recreation.”

The document continues to point out risks drugmakers should examine throughout the various stages of the data lifecycle, including: the generation and recording of data; processing of data into usable information; verifying the completeness and accuracy of reported data; retaining and retrieving data; and retiring and disposing of data.  

In assessing risks to the information, the EMA highlights the fact that complex and inconsistent procedures invite greater risk of data integrity failures. Instead, the agency recommends simple, well-defined procedures to minimize problems.

The EMA advises drugmakers to weigh the significance of data based on impact as well. As an example, the EMA compares critical quality attributes data to warehouse cleaning records — indicating that the former is far more consequential in decision making and crucial to risk mitigation.

The document drives the point home with an explicit reminder to drugmakers of their responsibility to incorporate data integrity management tools in all aspects of production, from the manufacture of materials to the delivery of drugs.

Earlier this year, the FDA issued final guidance on Applying Human Factors and Usability Engineering to Medical Devices, shedding light on the factors that companies should consider when developing devices to eliminate or reduce design-related problems that contribute to or cause unsafe or ineffective use.

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