UI Pharmaceuticals has a complete pharmaceutical quality assurance program 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 SeminarUI Pharmaceuticals Quality Assurance Program

UI Pharmaceuticals has a complete pharmaceutical quality assurance program to assure that your product is manufactured and tested in full compliance with cGMP regulations.

 

Quality control tests in the pharmaceutical industry are of the utmost importance. The University of Iowa Pharmaceuticals (UIP) has a rigorous pharmaceutical quality assurance program designed to ensure that FDA Good Manufacturing Practices and European Medicines Agency (EMA) GMP requirements are met.

  • 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 quality control tests in the pharmaceutical industry that UIP performs or our pharmaceutical quality assurance programs, or to schedule an audit of our facility and procedures, please Contact Us.