UI Pharmaceuticals has a complete pharmaceutical quality assurance program to assure that your product is manufactured and tested in full compliance with cGMP regulations. We are routinely inspected by FDA for compliance with cGMP regulations, with our last inspection occurring in May 2018. Since 2009 we have had 4 preapproval inspections with all of them resulting in approvable recommendations.
Quality assurance in the pharmaceutical industry is of the utmost importance. The University of Iowa Pharmaceuticals has a rigorous pharmaceutical quality assurance program designed to ensure that FDA Good Manufacturing Practices and European Medicines Agency (EMA) GMP requirements are met.
Aspects of our quality system include:
GMP and SOP training.
A comprehensive Quality Manual.
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.