cGMP Production

We maintain the ability to produce product under either GMP or nonGMP protocols, depending on your needs.

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.

On site GMP Walk in Freezer Storage

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.