From DCAT Value Chain Insights (VCI)
The US Food and Drug Administration has issued draft guidance, Data Integrity and Compliance With CGMP, to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. FDA said it issued the draft guidance due to an increase in observed CGMP violations involving data integrity during FDA GMP inspections, which have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.
"FDA expects that data be reliable and accurate," said the agency in the draft guidance. "CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models. "
The draft guidance, which is written in question and answer format, provides answers to 18 questions on compliance relating to data integrity.
Source: US Food and Drug Administration
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