FDA warns South Korean firm for inadequate training, insufficient personnel monitoring
A South Korean drug manufacturing firm was cited by the US Food and Drug Administration for having insufficiently trained personnel and for insufficient monitoring of aseptic processing areas.The deficiencies were detected in an October 2019 FDA inspection of Samchundang Pharm’s Hwaseong facility. The agency found that Samchundang failed to establish the suitability of the sterility test method it used for final release of its drug products and also didn’t determine whether the in-process bioburden test it used was suitable. “Suitability testing must be performed for each drug product to ensure the sterility test method is valid. Suitability testing establishes that contamination, if present, will be detected,” noted the FDA.
Samchundang had responded to the FDA that there were no specific requirements for method validation in its individual contract agreements. However, said the FDA, “We remind you that you are responsible for the quality of drugs you produce and test as a contract facility, regardless of agreements in place with product owners.”
The personnel monitoring program that the firm used allowed limits of 3 to 4 colony-forming units (CFUs) per plate to trigger an alert or action. “Manufacturing personnel who perform operations in aseptic processing spaces should normally maintain contamination-free…throughout operations. It is important to set action limits accordingly,” said the FDA, adding that “Growth observed on…samples taken from personnel who can perform any activities within the ISO 5 areas should trigger an appropriate investigation.”
The FDA also cited Samchundang’s procedure for microbial identification, which used visual morphology to group plates for isolate identification of a representative plate from a group. The firm’s response to the FDA “failed to include requirements for frequent identification of microorganisms to the species (or, where appropriate, genus) level in the ancillary cleanrooms beyond your aseptic processing room to maintain a current and valid database,” said the agency.
Finally, personnel were not trained at appropriate intervals specified in the firm’s standard operating procedures (SOPs), some were not certified as specified in SOPs and some personnel had no training records.
The FDA asked Samchundang to provide a detailed Corrective Action Preventive Action (CAPA) plan to address the inspection findings and arrange for a comprehensive independent review of personnel and environmental monitoring data for the previous 2 years.
Samchundang stopped production of over-the-counter drugs for distribution in the US, but FDA noted that the firm “failed to have adequate interim measures in place for products currently on the market within expiry.” To correct that latter problem, the agency asked for retrospective sterility testing for all reserve batches of any US-marked products still within expiry. The firm should provide FDA with testing protocol, timeline, results summary and proposed corrective actions for any out-of-specification results.
The FDA asked for notification should the firm intend to re-start manufacturing drugs for the US market in the future.