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

Lyophilization Cycle Development

 

Clinical Supply Manufacturing

 

Small Scale Commercial Manufacturing

 

Analytical Method Development and Validation

 

Routine Quality Control Analysis

 

Stability Assessment

 

Formulation Development

 

Comparator Products

 

Powder in a Bottle

 

Preformulation Studies

 

Active Pharmaceutical Ingredient (API) and Excipient Release Testing

 

QP Release Services

 

Training SeminarQuality Assurance

The University of Iowa Pharmaceuticals (UIP) has a rigorous quality assurance program designed to ensure that FDA Good Manufacturing Practices (GMP) and European Medicines Agency (EMA) requirements 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.
  • QP Release Services.

 

Incoming Material SamplingFor more information about our quality assurance programs or to schedule an audit of our facility and procedures please Contact Us.