The FDA’s New Draft Guidance

More recently, the FDA has begun seeing data integrity as a major concern to the violations discovered during audits. As a result, the FDA published its new draft guidance, Data Integrity and Compliance with cGMP, in April 2016 with the purpose to provide organizations with recommendations to ensure reliable and precise data documentation; which will ultimately produce safer products for consumers.

Guidance Overview

Still in draft form; the guidance is not yet official and remains open for comments and modifications. It is written in a questions and answers format, with a total of 18 questions, and covers topics of the Life Sciences manufacturing industry; including but not limited to, workflows, audit trails, personnel and reporting, electronic copies, and computerized system access.

Data Integrity and Compliance with cGMP clarifies “the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.”  As an expansion of the FDA’s present-day thoughts of the fine scope and application of Part 11.

The guidance was created in response to the increase in data integrity violations since 2011, as well as the rise in foreign inspections since 2012 when the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law.

How will the guidance affect your organization?

Although the new draft guidance is not yet “official,” it ties back to 21CFR Parts 210, 211, and 212.  This allows the FDA the ability to cite you on violations of Data Integrity and Compliance with cGMP.

Some CFR requirements with respect to data integrity include:

  • 211.68: “backup data are exact and complete,” and “secure from alteration, inadvertent erasures, or loss”
  • 212.110(b): data be “stored to prevent deterioration or loss”
  • 211.100 and 211.160: activities be “documented at the time of performance” and that laboratory controls be “scientifically sound”
  • 211.180: records be retained as “original records,” “true copies,” or other “accurate reproductions of the original records”
  • 211.188, 211.194, and 212.60(g): “complete information,” “complete data derived from all tests,” “complete record of all data,” and “complete records of all tests performed”.

With a soaring number of warning letters for data integrity violations, the FDA is on a mission to better the practices organizations carry out on a daily basis, and it is working. The industry is already seeing a significant impact from the draft guidance. I have experienced discussions on how a company can and should make changes to their own processes myself. Data Integrity and Compliance with cGMP has an immense opportunity to redefine the way organizations perform work; bettering the safety, efficacy, and quality of drugs.


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