As of this spring, FDA has resumed onsite inspections. As you prepare for your next FDA inspection, you are probably wondering what investigators consider the top GMP compliance issues.

(Keep in mind, quality should be the foundation of your GMP operations. Otherwise, it becomes “compliance for the sake of compliance” to use a term often referenced by seasoned FDA investigators. But more on this later!)

Investigators Hone in on Top Compliance Issues

Last year, Redica Systems Senior GMP Quality Expert Jerry Chapman covered the inspection-focused “Ask the Regulators” session at the 2021 PDA/FDA Joint Regulatory Conference. Common issues these investigators continue to see are:

  1. Lack of a “well-established” data governance plan to ensure data integrity.
  2. Need to review the audit trails for analytical instruments and identify the ones that are critical.
  3. Ineffective use of consultants. One panelist mentioned cases where a consultant failed to find any significant issues while a second one found several, signifying that the first consultant was not thorough.
  4. A robust quality culture that filters across all levels of an organization, starting with executive involvement.

Compliance that is Sustainable

At the 2021 ISPE Annual Meeting, FDA Commander (CDR) Tara Gooen Bizjak spoke about GMP compliance issues. She explained that companies need to adopt a “sustainable compliance ” mindset. By this, she stated that companies should not only meet minimal GMP requirements but focus on “mature systems and continually operate above that bar.”

Gooen Bizjak also identified data integrity as a concern, explaining she and her colleagues continue to “see different flavors of data integrity issues.” Additionally, she pointed to increasing reliance on contract operations. Here, quality culture is essential in ensuring that quality is carried over into the GMP operations at a contract manufacturing organization (CMO).

Sustainable compliance” was also identified as critical to quality systems by  FDA Director for the Division of International Drug Quality Carmelo Rosa in a separate PDA/FDA session. He used the example of responses to 483 observations and Warning Letters. In many cases, these responses address specific inspection findings but lack a comprehensive analysis of the quality system itself. 

Rosa used the example of one frequent citation–batch failure investigations. Since investigators continue to find batch failure investigation issues during inspections, it leads investigators to conclude that the quality system is lacking.

GMP Compliance Case Studies

For specific examples of recent GMP compliance issues, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented four in-depth case studies from recent GMP inspections conducted by the agency.

This should give you a sense of the top GMP compliance issues for 2022!

Additional Resources

FDA Regulators Address Data Integrity and Lab Audit Trails

Quality Culture Assessments and Records Request Responses

FDA on Cross-Contamination, Sustainable Compliance, and Contract Ops

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