FDA Warning Letter: GMP Requirements also apply to HPLC Analyses for Internal Use

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese drug manufacturing facility for significant CGMP violations, based on an inspection in December 2023.

HPLC

The letter, dated 13 June 2024, highlights issues with the company's HPLC testing. The company performed in-house HPLC testing without audit trails, failed to provide validation reports, and could not adequately explain the testing's purpose. Although the firm committed to implementing controls such as audit trails and electronic signatures, it did not address how it will use the in-house test results in the future.

Further Findings

Other findings include:

• Lack of process validation: After a request by the FDA investigators for process performance qualification (PPQ), the firm only provided equipment qualification reports during the inspection.
• Inadequate cleaning validation: The cleaning validation studies were incomplete.
• Inadequate equipment controls: Failure to maintain equipment and monitor alarms correctly.
• Inadequate microbiological laboratory methods: The firm failed to establish and follow required laboratory control mechanisms.

Conclusion

These issues highlight significant lapses in maintaining CGMP standards, which can affect product quality and safety. The FDA placed the firm on Import Alert 66-40, preventing the importation of their products into the USA. In the meantime, the firm has committed to ceasing production and outsourcing manufacturing.

For more details, you can read the full Warning Letter on the FDA's website.