Before commercial production can begin at the Biologics Manufacturing Centre, the NRC must complete a critical, but also complex and time-consuming process to demonstrate compliance with good manufacturing practices (GMP). One of the GMP requirements is the completion of a process called commissioning, qualification and validation, which is required for all new biomanufacturing facilities in Canada.
GMP compliance is an integral part of the Biologics Manufacturing Centre design. GMP regulations ensure that drugs meet the quality standards appropriate to their intended use. GMP compliance requires that the people, premises, processes, products and procedures involved in making a vaccine are doing exactly what they are supposed to do with repeatable precision.
With an end product intended to be administered to people, absolute GMP compliance is required to ensure vaccines produced in the facility are consistent in safety, identity, strength, purity and quality—every single dose, every single time.
Essentially, the commissioning, qualification and validation process tests all of the functionality of a facility. It is intended to ensure that each piece of equipment, as well as each room and each system, does exactly what it is supposed to do. As part of this process, the facility itself, as well as all of the rooms and each piece of the new equipment, need to be "qualified" prior to use. All of the qualification work must be completed and documented before being reviewed by Health Canada.
As with any completely new facility with all brand new equipment, minor challenges are expected. As part of the rigorous commissioning, qualification and validation process, all issues need to be formally addressed by the Biologics Manufacturing Centre qualification teams. Similar to an audit, for any issue—big or small— the team will investigate and document the root cause, then propose, evaluate, approve, implement and document the corrective action.