CGMP-compliant manufacturing
What is CGMP-compliance?
Current Good Manufacturing Practice (CGMP) is the adherence to up-to-date, FDA regulations (21 CFR 210 &211) for the preparation of drug products, biologics, or devices for administration to humans or animals.
Why is it needed?
It assures that all equipment, methods and materials used in the manufacturing process are suitable; that all personnel are well trained and proficient; that facilities are kept clean and particle free; and that any manufactured product is stringently tested to verify safety and efficacy before use.PDM Core Services
Service 1:
CGMP-compliant pre-clinical trial runService 2:
CGMP-compliant batch run
What do I need to do?
Please contact the PDM Core for specifics on the program and individualized service agreements.E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu