CPU Production Facility The SGS CPU production facility is authorized with Good Manufacturing Practices (GMP) by the Belgian Health Authority. As the first Phase I holder of a GMP authorization, SGS routinely delivers extended manufacturing services to its clients, managing the investigational medicinal product (IMP) manufacturing process during the set-up of the clinical trial in the most efficient way. This facilitates ordering and production of small IMP volumes inherent to Phase I trials.
Secondary packaging including labeling batch-release of imported products: • Sterile products • Aseptically prepared • Biological products • Immunological products • Challenge agents
We can perform a variety of manufacturing activities within the SGS production facility, including: Manufacturing of non-sterile products including active pharmaceutical ingredients (API) weighing): • Hard capsules (filling with powder or with liquid) • Solutions, to be used internally Primary packaging of: • Hard capsules • Solutions, to be used internally
Formulation and Clinical Manufacturing Our global Center of Excellence for Formulation and Clinical Manufacturing – provides enhanced formulation research and development services for Phase I, Phase II and Phase III trials. Operating out of MHRA- and FDA-inspected facilities, we support drug manufacturers throughout all stages of clinical development: pre-formulation work, formulation, dosage form design and optimization.
For each clinical trial a study specific production and/or dispensing protocol is set-up and approved by the sponsor. The production facility assembly suite complies with most sponsor requirements for clinical assembly. A team of production facility staff is dedicated to GMP manufacturing activities, and includes 2 in-house Qualified Persons, a Head Quality, Head GMP Production and GMP operators and QC checkers.
Made with FlippingBook - Online magazine maker