Korean Firm Cited for Data Controls, Cleaning Validation

The FDA came down on API manufacturer Hanmi Fine Chemicals for cleaning validation and data control violations observed at its Gyeonggi-do, Korea plant.

The facility did not have documented evidence that its cleaning procedures could consistently remove residues from the surface of equipment to make them acceptable for processing drug substances and intermediates. One of the firm’s SOPs for cleaning validation did not include limits for cleaning agent residue and detection methods that would prevent product-to-product carryover.

“In addition, your firm failed to have written procedures for re-evaluating the cleaning validation program upon entrance of new active ingredients in the manufacturing facility,” the agency said in the Form 483, adding that the firm did not consistently perform risk assessments on drug substances manufactured on shared equipment — such as reviewing each new drug substance’s toxicological data, solubility and pharmacological effects.