#Attribute capability study template verification

1 While implementation is becoming a regulatory expectation, CPV can provide benefits beyond compliance by identifying opportunities to improve production processes and ultimately, the reliability of drug quality and supply.Д¬PV is the third stage of the process validation life cycle.

#Attribute capability study template verification

In 2011, the FDA introduced guidance on the process validation life cycle, including continued process verification (CPV). 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. Thus, CPV is about maintaining control within specification and so does not normally lead to a formal investigation. It is designed to detect variation within specifications.

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.Д¬PV involves gathering data related to CQAs and CPPs, as well as analyses that reveal any statistical signals that become evident over time. This paper describes how signals can be developed and evaluated in support of CPV in the biopharmaceutical industry.