BioOutsource Contract Testing Facility Passes FDA Inspection
News Mar 03, 2016
Sartorius Stedim Biotech is pleased to announce that the Glasgow facility of its subsidiary Sartorius Stedim BioOutsource Ltd. has successfully passed an inspection by the U.S. Food and Drug Administration (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.”
Absolute Antibody and Kerafast Merge Increasing Access to Unique Reagents and Recombinant Antibody TechnologyNews
Absolute Antibody Ltd., and Kerafast Inc., have announced a merger of the two companies. The merger brings together two companies with a shared commitment to improving the selection of research tools available to the scientific community.READ MORE
Lonza to Establish Cell- and Gene-Therapy Centers of Excellence to Accelerate GrowthNews
Lonza will establish Centers of Excellence for Cell and Gene Therapy to support and accelerate the growth of this priority area for the company.READ MORE
Comments | 0 ADD COMMENT
3rd Annual Bioprocessing of Advanced Cellular Therapies
May 29 - May 30, 2018