CPV Flashcards
How would you design a CPV programme – what tools would you use and what would they tell you?
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.
The review frequency should be established with the monitoring plan and should consider:
Relative risk of a parameter or attribute deviating from its acceptable range
Manufacturing frequency
Level of historical process knowledge
Manufacturing plant’s technological capability to collect and analyze the data
A CPV plan shall be established with the following components, including a rationale for each:
Parameters and attributes to be monitored
CPV limits for each parameter and attribute combination
Frequency of trend evaluations
Statistical signals to be evaluated
Default responses for each parameter-signal combination
The rationale can be risk based and should include an explanation of which process behaviors may merit further analysis. Ideally, each default response should be determined from a risk-based strategy that considers the criticality of the parameters, the nature of the signals, and the performance/capability of the process parameters.
Any changes to control limits, signals, or processes that result from evaluation should be managed by the system most appropriate for the change (i.e., change control or CAPA). Quality approval is required to close out a response to signal for all three categories (escalation, evaluation, no action).
