FDA Warning Letter Highlights Cleaning Validation Expectations in GMP Compliance

The FDA emphasizes documented evidence as a core requirement in Good Manufacturing Practice (GMP). A recent Warning Letter to Aspen Biopharma Labs Pvt. Ltd., India illustrates deficiencies in cleaning validation. During inspection, the FDA observed no cleaning validation despite the company noting this internally in a deviation report. Additionally, equipment labeled as “cleaned” was found to be filled, highlighting risks of cross-contamination.

The FDA expects companies to provide:

• An overview of the validation program and associated procedures.
• Schedules and protocols for process performance qualification (PPQ) and equipment/premises qualification.
• Updated work procedures for cleaning validation and verification.
• A retrospective review assessing potential cross-contamination for all shared equipment.
• A CAPA plan addressing risks identified in the review.

Worst-case scenarios should be considered for highly toxic, high-dose, low-solubility, or hard-to-clean products, including critical swab points and standing times before cleaning.

Conclusion: All Warning Letter responses must include documented corrective measures addressing identified deficiencies.

13-10-2025