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