FDA EIR - Bioreliance Ltd. - September 22, 2017

An FDA inspection of BioReliance Ltd. in Glasgow, UK, was conducted from September 18-22, 2017. This routine CGMP surveillance focused on the company's contract manufacturing of licensed bulk vaccine and biologic therapeutic drug substances, and human drug control testing. The regulatory framework for the inspection included compliance programs 7356.002F, 7356.002M, and 7356.002, alongside ICH Q7 guidance for active pharmaceutical ingredients. The inspection covered quality, facilities and equipment, production, and laboratory control systems.

The inspection resulted in a three-item FDA-483, identifying several main violations. These included the quality control unit's failure to fully adhere to procedures for change management and investigation into unexplained discrepancies, non-compliance with written procedures for cleaning and maintaining manufacturing equipment, and insufficient separation or definition of areas to prevent contamination during aseptic cell culture operations. Additionally, the firm's Validation Master Plan was found to be vague, lacking specific schedules and clear acceptance criteria, and quality agreements for products destined for the U.S. market did not explicitly reference U.S. regulations like 21 CFR 210/211.

BioReliance Ltd. committed to providing a written response to the FDA-483 observations within 15 working days. Recommended actions included re-evaluating an ongoing investigation into micropipette calibration failures to ensure use conditions are reflected, validating changes to analytical methods, and advancing their data integrity program, with follow-up planned for future inspections.