GMP Training and Biomanufacturing Program
The mission of the UMBI GMP Training and Biomanufacturing Program is to provide Contract Manufacturing and Process Development to the biotech industry, and to provide Training to both the biotech industry and the University of Maryland students.
The contract manufacturing will be performed under CGMP (Current Good Manufacturing Practices) as regulated by the FDA. Material produced in the facility will be appropriate for use in Phase I/II clinical trials and/or to facilitate research in scale up of production processes in partnership with other CGMP production companies.
The facility will also serve as an archetypal GMP clinical trial material production facility. Training will be provided in classroom and classroom-lab formats on topics such as:
· Quality Assurance – Quality Systems · Quality Control
· Assay Validation · New Analytical Technologies
· Specific Processing Equipment · Unit Operations
The GMP Program can accommodate a variety of working relationships including collaborations, subcontracts, and fee-for-services. Call 240.314.6350 to discuss which arrangement is best suited for your project.
What is CGMP?
Current Good Manufacturing Practices (CGMP) consist of the regulations, guidelines and recommended practices issued by the FDA and other international regulatory authorities as well as current industry practice. They form the basis for production and testing of pharmaceutical products that are safe and effective for human use. Regulatory publications are necessarily vague so that manufacturers have the opportunity to incorporate innovations into their products. Thus the practitioner of cGMP must strive to be up to date on the latest innovations. CGMP compliance ensures that the products produced meet specific requirements for identity, strength, quality, and purity. FDA regulates practitioners of CGMP using the following tools:
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