GMP Facility
QSI RENU operates a certified Good Manufacturing Practices (GMP) facility on Northwestern’s downtown Chicago campus. This facility provides researchers with a controlled environment to manufacture biomaterials and potential products, supporting translation from the laboratory to the clinic.
*The facility is outfitted with a biosafety cabinet, lyophilizer, and two fume hoods.
Regulations and Standards
QSI RENU's GMP facility has been certified to meet the following regulations and international standards.
Regulations QSI RENU adheres to:
- 21 CFR Part 210 and 211, Current Good Manufacturing Practice for the Manufacture, Processing, Packaging, or Holding of Drugs
- 21 CFR Part 820 Quality System Regulation
International Standards QSI RENU follows:
- ISO 14644-1:2015, Cleanrooms and Associated Controlled Environments
- ISO 13485:2016, Medical Devices - Quality Management Systems
- ICH Q10, Pharmaceutical Quality System
- ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
More Information
If you are interested in using the GMP Facility or learning more about the process, please complete the form linked below. Alternatively, please reach out to the QSI RENU team directly.