Thursday, 13 December 2018

Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry


FDA has issued a new guidance document on data integrity “Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry”.

The introduction reads:

“In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FD&C Act regarding safety, identity, strength, quality, and purity. Requirements with respect to data integrity in parts 211 and 212 include, among other things…”


As noted in the Federal Register:

“The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers.” The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance has been developed in response to an increase in findings of data integrity lapses in recent inspections. FDA expects that all data be reliable and accurate. 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 on their process understanding and knowledge management of technologies and business models.”

The document can be found here: https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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