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 About the GMP Program
The mission of the UMBI GMP Training and Biomanufacturing Program is to enhance the economic development of the biotechnology community by providing Contract Manufacturing and Process Development services, and by providing Training to both the biotech industry and to University of Maryland students.
The contract manufacturing will be performed under cGMP (Current Good Manufacturing Practices) as regulated by the FDA. Materials produced by the GMP Program 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
- New Analytical Technologies
- Assay Validation
- Specific Processing Equipment
- Unit Operations
The GMP Program can accommodate a variety of working relationships including collaborations, subcontracts and fee-for-services.
Contact us to discuss which arrangement is best suited for your project.
Click here to view the GMP Program Brochure
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:
21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part
21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 600 - Biological Products: General
21 CFR Part 11 - Electronic Records; Electronic Signatures
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