MassBiologics' Quality Assurance group is responsible for establishing, revising and monitoring compliance to our quality systems. The team is responsible for the following:
- Review and approval of SOPs, Batch Records and Test Methods
- Release of manufacturing suites and utilities for cGMP use
- cGMP training of staff
- Approval of cGMP vendors and raw materials, including cell banks
- Release of bulk drug substance and final drug product
- Audits (internal, client, regulatory and vendor audits)
- Change management, deviation and corrective and preventive action systems.
The quality assurance group is comprised of individuals experienced in management of FDA licensed and investigational biologic products, with particular strengths in the assurance of aseptic processing, product sterility, and clinical phase appropriate implementation of cGMP's.
The MassBiologics' Quality team is responsible for establishing Quality Assurance Agreements with each client to ensure that regulatory roles and responsibilities are clearly defined to the satisfaction of each party.