FDA EIR - Bioreliance Corporation - July 13, 2018

A U.S. Food and Drug Administration (FDA) inspection was conducted at BioReliance Corporation's Rockville, MD facility from July 9-13, 2018. The inspection, part of the Team Biologics FY 2018 work plan, focused on the company's role as a contract testing laboratory for pharmaceutical and biologics industries, under compliance programs for biological drug products. Following the five-day assessment, the FDA issued a two-item Form 483, detailing significant observations requiring corrective action. The inspection identified two main areas of concern. Firstly, the firm's data integrity practices for electronic records were deemed insufficient. Backup data was not adequately assured for completeness or security against alteration, erasure, or loss. Furthermore, electronic records did not meet operational system checks to ensure their trustworthiness and reliability. Specifically, the Quality Unit

s internal audit procedure lacked defined frequencies for auditing critical systems and a validated method for sampling long-term archived electronic records. The electronic records retention procedure also failed to detail how corrupted or missing archived data should be managed. Secondly, the Quality Unit demonstrated a systemic failure in the timely review and approval of change controls. This resulted in numerous general change control records, some related to the installation of new laboratory equipment or system updates, remaining open for over two years, hindering timely closure. Management acknowledged the necessity to strengthen their change control program as an area of focus. The issuance of the FDA 483 mandates BioReliance to formally address these observations with the agency.