FDA Perspective on Responsibilities of Quality Assurance

FDA Warning Letters offer insight into CGMP regulations, with a recent letter highlighting deficiencies in quality assurance. The letter cited 21 CFR 211.22, focusing on a U.S. manufacturer’s failure to comply with quality unit responsibilities.

Process Validation Issues:

The FDA criticized inadequate validation of the water system, referencing 21 CFR 211.100. They requested a detailed validation program, Process Performance Qualification (PPQ), equipment qualification, and risk assessments for defective systems.

Cleaning Validation Deficiencies:

Under 21 CFR 211.22 and 21 CFR 211.67, the FDA flagged the lack of cleaning validation, emphasizing improvements for "worst-case" scenarios, including toxic or hard-to-clean products and maximum cleaning hold times.

Stability Studies Lacking:

Citing 21 CFR 211.137, the FDA noted missing stability studies for product expiration dates, calling for a comprehensive review, ongoing testing, and CAPA plan.

 Overall, the FDA emphasized the need for stronger quality assurance oversight in process validation, cleaning, and product stability. Full details are available on the FDA website.