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FDA released a draft guidance in early April 2016 clarifying the expectations for maintaining data integrity in cGMP compliance. The guidance follows in the wake of increased findings of data manipulation and integrity concerns by agency investigators, par- ticularly in India and China, which have been prompting warning letters and import bans. Written in Q&A format, the guidance lays out FDA’s position on 18 topics, including when and how computer systems need to be validated, electronic account access and accountability concerns, proper record-keeping practices, and how to address data integrity problems as they are brought up in inspections, warning letters, or other regulatory actions. [See IPQ March/April 2014 Monthly Update for a detailed analysis of the increasing trend in data integrity findings.]
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
