Quality is every patient’s right and every employee’s responsibility. Quality provides a competitive advantage and is ingrained in Matica Biotechnology’s core principles, from concept through the final product. Our clients’ cell and gene therapy products touch human lives; therefore, quality is the true measure of our success.
Quality Management System (QMS)
Matica Bio’s Quality Management System (QMS) is designed to meet United States and international regulatory and statutory requirements for viral vector production and cell banking, as well as Matica Bio’s own commitment to the quality of the products produced at our facility in College Station, Texas.
Matica Bio’s Quality Control Components
- Development of Specification
- Incoming Materials Testing
- Validation of Analytical Methods
- Testing and Release of Incoming Raw Materials
- Invalid Test Results Program
- Recording and Reviewing Test Results Documentation
- In-Process Testing
- Final Release Testing
- Execution of Test Methods in a GMP Environment
- Product Stability Testing
- Environmental Monitoring to ISO Standards
- Qualification of Analytical Methods
- Out-of-Specification Program
- Out-of-Trend Program
- Contamination Control Program
- Stability Program Testing and Reporting
Matica Bio has established and maintains written procedures for internal quality auditing to ensure all QMS elements are clearly defined, effectively followed and suitable for Matica Bio’s processes.
The Quality System is applicable throughout the product life cycle, including technical activities for clinical and commercial products.
Quality planning is necessary prior to taking on any project at Matica Bio. It is imperative that we assess each project’s fit for our facility by completing an initial project risk assessment. Once this assessment is completed and the decision is made to accept a project, Matica Bio will then initiate the project through technology transfer. Central to the successful execution of each client project is the development of a Quality Agreement to ensure we are all aligned in our quality expectations. This Quality Agreement will be a shared document that aligns the expectations of Matica Bio with those of our client.
Our Quality Assurance Components
- Change Management
- Internal/External Auditing
- Corrective Actions and Preventative Actions (CAPA)
- Regulatory Compliance
- Deviation Management
- Complaints, Product Defects, Recalls
- Supplier Management
- Risk Management
- Label Control
- Batch Record Review
- Product Release
- Material Release
Our Validation Components
- Qualification of Equipment/Analytical Instruments
- Validation of Computer Systems/Software
- Qualification of Facilities/Utilities