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FDA Warns Korean Drugmaker Over Poor Aseptic Practices, Patchy Lab Records

Posted 16 October 2018 | By Ana Mulero 

FDA Warns Korean Drugmaker Over Poor Aseptic Practices, Patchy Lab Records

South Korea-based Hanlim Pharm Co. drew a US Food and Drug Administration (FDA) warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP).

The FDA inspection of the company’s drug manufacturing facility in Gyeonggi-do earlier this year concluded that similar GMP violations had been observed during FDA visits to the site in 2014 and 2016. The repeat observations underscore a need for prompt remediation, with the two new violations in the warning letter being related to aseptic practices and data integrity.

Poor aseptic practices observed during the company’s setup and filling operations for the manufacturer of a sterile solution “posed a significant risk of microbial contamination,” according to the 3 October warning letter posted on Tuesday. One example relates to an operator that had reportedly “continued equipment set-up activities...without disinfecting his hands, which could transfer the surfaces and components in the ISO-5 aseptic filling zone.”

Other issues cite Hanlim Pharm operators “stopping the clear bottle jams more than 10 times in a 90-minute period” and “on several occasions, operators leaned their heads and torsos...over open bottes” to then restart the line “without cleaning open bottles that may have been contaminated by their interventions,” the agency said. The related GMP violation cites a failure to monitor viable organisms in the aseptic filling area and personnel’s set-up activities.

On ensuring quality and integrity in laboratory testing data, the inspection found Hanlim Pharm had been lacking proper controls in its computerized laboratory software system.

The company’s system was deemed inadequate as three quality control team leaders had administrator privileges, including for file deletion or modification, that could result in tainted or incomplete GMP data. FDA also found two laboratory software systems “had unlocked time and date functions, which allowed users to change the recorded dates and times of analyses.”

Another GMP violation points to the company’s failures in ensuring all laboratory records include complete data. “Our investigator observed a quality control analyst and laboratory team leader signing and backdating a test record,” the agency added. “In the microbiology laboratory, we also observed an analyst recording microbiological test results from environmental monitoring settling plates before reading the plates, as well as recording results for a previous day.”

The agency called on the company to respond to the cited violations by providing a risk assessment on aseptic technique and cleanroom behavior, and an investigation into the extent of the inaccuracies seen in data records and reporting, among other corrective and preventive actions prior to consider lifting of the import alert the agency placed on the company in May.

Hanlim Pharm


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