FDA asks Gulf to hire 3rd party to fix data integrity failings
US Food and Drug Administration (FDA) inspectors visited Gulf Pharmaceutical Industries (Julphar) in September and found multiple GMP (good manufacturing practice) violations at the Airport Road, Ras Al Khaimah site. Many of the problems cited in the warning letter concern data integrity failings.
“We highly recommend that you hire a third-party auditor, with experience in detecting data integrity problems, who may assist you in evaluating your overall compliance with cGMP”, the FDA wrote in a warning letter dated February 23.
Julphar deleted electronic raw data for most HPLC (high-performance liquid chromatography) assays after two years to clear space. Also, paper copies of HPLC results were treated as raw data despite the lack of analytical metadata, such as instrument conditions, in this format.
Some of the problems are more basic. Earlier this month our sister publication Outsourcing-Pharma reported on a contract laboratory that was warned by the FDA for using one password for all staff. A similar failing was found at Julphar’s HPLC unit.
“All laboratory analysts share the same password for the HPLCs in the QC analytical chemistry lab and Omnilog in the microbiology lab. In addition, analysts have access to the HPLCs which allow them to create and/or modify validated methods”, the FDA wrote.
Problems found by inspectors raise “concerns with all data generated by [Julphar]”, the FDA wrote. In its October response Julphar committed to improve quality assurance but the FDA fears the investigation “is not comprehensive enough to determine the extent and impact of the problem”.
Seven years, still no smoke
Other problems relate to sterility. In 2004 FDA inspectors found Julphar failed to run smoke studies for its ampoule filling line. Last year inspectors found the same failing and its inability to comply with this aseptic requirement, detailed in FDA guidance, reflects badly on Julphar.
“The lack of possessing these data after having seven years to complete them does not bode well with the FDA. The extent of these observations suggests that any product manufactured in such a facility is at risk of non-sterility”, Barry Friedman, a regulatory compliance consultant, wrote on his blog.
In response to the failings the FDA placed Julphar under an import alert at the end of January. The import alert bans Julhphar from importing drugs manufactured at the Ras Al Khaimah site into the US until it complies with cGMPs.
“Provide a complete corrective action plan that includes a retrospective review of the analytical data and batch records for all products manufactured at your facility that remain within expiration. In addition, provide the actions taken to prevent recurrence of the problem”, the FDA wrote.
