US FDA Guidance Looks to Stem ‘Major Problem’ of Data Integrity

Monday, April 18, 2016

Source: in-PharmaTechnologist

The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites. The US Food and Drug Administration (FDA) is hoping to reduce the problem through draft guidance issued last week to help firms ensure that data is reliable and accurate.

"FDA has increasingly observed cGMP violations involving data integrity during cGMP inspections," the document says. "Ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, and of the FDA's ability to protect the public health."

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