FDA’s New Data Integrity Guidance — Highlights & Observations

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The scope of the FDA document includes drugs, biologics, and positron emission tomography drugs. The agency also states the requirements are consistent with the requirements in ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, thus expanding the scope of the document to APIs and drug substances. The FDA states it is the “role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value. …”

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