cGMP Production

Key Elements of our Current Good Manufacturing Practices (cGMPs)

  • Independent Quality Assurance (QA) department as the center of our quality system
  • Change Controls (CCs)
  • Complaints
  • Corrective Actions (CARs)
  • Deviation Reporting (DRs)
  • Record Keeping Practices
  • Document Control
  • Internal Audits
  • Lot Release
  • Record Review
  • Post Donation Information and Lookbacks (PDIs)
  • Supplier Corrective Actions (SCARs)
  • Supplies Management
  • Training
  • Trend Reporting
  • Validation Protocols
  • Extensive library of Standard Operating Procedures (SOPs) that range from donor acceptance and quarantine thru the shipment of finished product.
  • Capability to perform in house calibration, certification, and validation of all equipment directly used in production.
  • Experience in design and development of critical components related to production.
  • Standing IACUC committee for the rapid review of protocols.
  • On site GMP Validated Walk-in Freezer space available.

Proven Results

  • Produced over 35,000 liters of plasma as a raw material of antibodies for parenteral administration to humans under a cGMP compliant project.
  • Successfully audited by contactors numerous times with no significant findings identified.