Continued process verification (CPV) signal responses in biopharmaceuticals
This paper describes how signals can be developed and evaluated in support of CPV in the biopharmaceutical industry. Implementation of CPV, in addition to meeting regulatory expectations, can also provide a basis for continuous improvement of production processes and hence greater consistency of product quality and assurance of supply.
CPV involves gathering data related to CQAs and CPPs, as well as analyses that reveal any statistical signals that become evident over time. It is designed to detect variation within specifications. Thus, CPV is about maintaining control within specification and so does not normally lead to a formal investigation. This paper provides several examples of signal response and escalation within the quality system where necessary as a model of a risk-based approach to CPV.