The University of Iowa Pharmaceuticals has a complete quality system to assure that your product is manufactured and tested in full compliance with cGMP regulations.
Quality Assurance
The University of Iowa Pharmaceuticals (UIP) has a rigorous quality assurance program designed to ensure that FDA Good Manufacturing Practices (GMP) are met. Various facets of this program include:
- GMP and SOP training.
- Routine balance and equipment calibration (managed with Calibration Manager Software System).
- Routine environmental monitoring and controls.
- Validation of all equipment, software, and systems.
- Cleaning verification of any non-dedicated equipment after manufacturing.
- An extensive preventative maintenance program with change control.
- Full auditing of all batch records and laboratory data for accuracy, authenticity, and completeness.
- Establishment of quality agreements with each client.
For more information about our quality assurance programs or to schedule an audit of our facility and procedures please Contact Us.