FDA manufacturing guidance issued in response to 'troubling' violations

Questions surrounding data integrity are tackled in new guidance issued by the US Food and Drug Administration (FDA).

This comes in response to an increasing number of current good manufacturing practice (CGMP) violations involving data integrity observed during CGMP inspections in recent years, the FDA says.

The regulator describes this rise in violations as ‘troubling’ because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, effectiveness, and quality of drugs, and of the FDA’s ability to protect the public health.