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FDA Updates Guidance On Data Integrity And Compliance

 
• By Grace Montgomery

Preventing data integrity lapses has been key to the FDA’s strategy concerning cGMP compliance in recent years, and the agency has now updated guidance to help pharmaceutical manufacturers implement best practices.

Data integrity
FDA revises guidance on data integrity and compliance • Source: Shutterstock

Guidance on data integrity and compliance with current good manufacturing practice (cGMP) has been revised by the US Food and Drug Administration (FDA), as part of the agency’s “multi-layered approach to ensuring the integrity of data”.

Updating a draft version released in 2016, the guidance, Data Integrity and Compliance With Drug CGMP, is a response to public comments requesting additional details on the FDA’s thinking...

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