Certified quality of analytical services for developers of biologics and biosimilars.
Sartorius Stedim Biotech announces that the Glasgow facility of its subsidiary Sartorius Stedim BioOutsource Ltd. has successfully passed an inspection by the FDA.
In January 2016, the FDA Compliance Safety Officer spent two days at BioOutsource’s facility reviewing its quality systems and their application to the analytical services that support the testing of biologics, vaccines and biosimilars. The inspection confirmed that the Glasgow site is compliant with the principles and guidelines of Good Manufacturing Practices (GMP). Not a single Form 483 observation for non-conformance was issued.
At the closing meeting, the FDA inspector was very satisfied with the facility and complimented Sartorius Stedim BioOutsource on its GMP systems, organisation during inspection and the expertise of its team members. The success of this FDA inspection, combined with the positive feedback from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2015, as well as reports from numerous biopharma clients that have visited and audited the Glasgow facilities in recent years, demonstrates BioOutsource’s commitment to maintaining excellence in its quality systems.
Gerry Mackay, CEO at BioOutsource stated: “We’re delighted with the positive outcome of our FDA inspection, because it shows that we are committed to offering quality analytical and safety testing. This provides biopharma firms with confidence that we are a partner they can trust with their biologic and biosimilar drug development programmes.”