FDA EIR - Bioreliance Ltd. - September 27, 2019

An FDA routine surveillance inspection of BioReliance Limited, a contract testing laboratory and active pharmaceutical ingredient (API) manufacturer in Glasgow, United Kingdom, was conducted from September 23 to 27, 2019. The inspection assessed the company's adherence to current Good Manufacturing Practices (cGMP), governed by 21 CFR Parts 210 and 211, and relevant compliance programs for drugs and biologics. The inspection identified three significant observations, issued on an FDA Form 483. Firstly, the company failed to consistently follow written sanitation procedures for cleaning and maintaining manufacturing equipment, specifically biosafety cabinets. This was a repeat observation, with video evidence showing incomplete cleaning, such as neglecting glass visors. Secondly, aseptic simulation studies (media fills) used for operator qualification were found to be deficient. They did not accurately represent routine production conditions, particularly regarding the number of personnel involved in aseptic filling, despite a previous corrective action requiring additional operators. Thirdly, changes or repairs to critical equipment, such as the installation of a peristaltic pump on HVAC units to address condensation, were performed without adequate review by the quality unit through a formal change control process. BioReliance management acknowledged the observations, indicating their understanding and commitment to providing a written response to the agency, which was subsequently received on October 17, 2019. The findings highlight areas where improved adherence to established procedures, more realistic aseptic process simulations, and robust quality oversight of equipment modifications are necessary to ensure product quality and patient safety.