Quality Oversight
The Paragon Quality Control and Quality Assurance Group (QA/QC) oversees the entire cell banking process from the validation of equipment to the approval of the required documents (SOPs, batch records, validation reports, etc.) to the release of the cell bank to the client.
The QA/QC Group will interact directly with your Quality representative to ensure the facility and procedures meet with your expectations as well as requirements of the appropriate regulatory authority.
As part of our Quality Assurance procedures
- All cell banks are segregated and produced on a campaign basis
- Between cell banking projects Paragon deploys validated change-over and cleaning procedures
- All raw materials are sourced from QA-approved vendors and released according to Paragon’s raw materials release procedures.
- Prior to initiating any cell banking project, seed stock is certified as free of Mycoplasma or bacteriophage, and tested for sterility.
Contact us for additional information or to request a proposal.