Control of raw materials is absolutely critical to our company and Quality Management System. Ensuring that we have full traceability of our raw materials back to the manufacturer provides additional confidence that our customers are receiving high quality and consistent finished product. The development of specifications, part numbers and lot numbers for all critical materials, subassemblies and finished product further ensures full traceability.

Quality system documentation is controlled using a software platform that is 21 CFR Part 11 compliant, ensuring that the documentation is created, reviewed, and approved by the appropriate parties, with only the most current versions available for use. Production processes are executed by trained personnel using approved protocols and reports. Batch records are created for each lot manufactured and are reviewed by the quality unit before being dispositioned. We oversee our records to ensure that they provide historical accounting that is accurate, legible, and readily available as needed, including during audits.

Critical equipment goes through standard IQ/OQ/PQ procedures with quality oversight. Preventive maintenance and calibration schedules are maintained for all critical equipment. Secondary monitoring systems with real-time and automated alert systems have been installed for cold storage equipment

Production processes are validated with approved protocols and reports.

The quality and consistency of our product begins with the oversight and initial qualification of critical suppliers, as well as ongoing monitoring of supplier performance. Nucleus Biologics develops quality agreements with our critical suppliers as deemed necessary. Our quality unit actively partners with suppliers to ensure the resolution of supplier nonconformance.