Draft Guidance: Data Integrity and Compliance with cGMP

  • By: Staff Editor
  • Date: November 22, 2016
  • Source:
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Draft Guidance: Data Integrity and Compliance with cGMP

US FDA has lately observed increased cGMP violations involving data integrity during 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.

This guidance is intended to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.

  • Part 210 covers cGMP in manufacturing, processing, packing, or holding of drugs
  • Part 211 covers cGMP for finished pharmaceuticals
  • Part 212 covers cGMP for Positron Emission Tomography Drugs

Key Questions Addressed in this Guidance Include:

  • Clarification of the terms as they relate to cGMP records.
  • When is it permissible to exclude CGMP data from decision making?
  • Does each workflow on our computer system need to be validated?
  • How should access to cGMP computer systems be restricted?
  • Why is FDA concerned with the use of shared login accounts for computer systems?
  • How should blank forms be controlled?
  • How often should audit trails be reviewed?
  • Who should review audit trails?
  • Can electronic copies be used as accurate reproductions of paper or electronic records?
  • Is it acceptable to retain paper printouts or static records instead of original electronic records from stand-alone computerized laboratory instruments, such as an FT-IR instrument?
  • Can electronic signatures be used instead of handwritten signatures for master production and control records?
  • When does electronic data become a cGMP record?
  • Why has the FDA cited use of actual samples during “system suitability” or test, prep, or equilibration runs in warning letters?
  • Is it acceptable to only save the final results from reprocessed laboratory chromatography?
  • Can an internal tip regarding a quality issue, such as potential data falsification, be handled informally outside of the documented CGMP quality system?
  • Should personnel be trained in detecting data integrity issues as part of a routine cGMP training program?
  • Is the FDA investigator allowed to look at my electronic records?
  • How does FDA recommend data integrity problems identified during inspections, in warning letters, or in other regulatory actions be addressed?

Related Training:

Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

Click here to download the file
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