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URMC / Clinical Materials Services Unit / Quality System


Quality System

CMSU’s Quality System is designed to comply with International Standards for the production of Investigational Product (IP); 21 CFR parts 210 and 211 (current Good Manufacturing Practice (cGMP) regulations for the production of Pharmaceuticals, 21 CFR Part 812 (Investigational Device Exemptions) and Volume 4, Good Manufacturing Practices, Annex 13, Manufacture of Investigational Medicinal Products.

This level of quality is achieved through adoption of a system of procedures that reflect the competence of the CMSU to existing clients, potential clients, and independent auditing authorities.

Achievement of this policy involves all staff, who are individually responsible for the quality of their work, resulting in a continually improving work environment for all. All employees are trained in current SOP's to ensure proficiency and understanding of our quality systems.  This policy is provided and explained to each employee by the Senior Management Team of the CMSU.

Elements of the Quality System

  • Standard Operating Procedures which cover each aspect of Operations and Quality Assurance activities
  • GMP and GCP Training programs
  • Validation of critical Systems; Environmental, Security, Label Production
  • Change Control, CAPA and Preventative Maintenance Programs for all critical systems
  • Vendor Qualification Program
  • Self (Internal) Audits by QA
  • Inspection activities at each step of Operations
  • Full Master Batch Record Review in preparation for Release of Product to the field