Continued Process Verification

Continued Process Verification and Informatics (CPV&I) resource page represents an industry best practice response to the US Food and Drug Administration (FDA) 2011 process validation guidance on Stage 3, “Process Validation: General Principles and Practices”*.

About CPV


Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in process validation. Its central purpose is to ensure that processes are in a constant state of control, thus ensuring final product quality. Central to effective CPV is a method with which to identify unwanted process inconsistencies in order to execute corrective or preventative measures. Once quality standards are set in place they must be monitored with regular frequency to confirm those parameters are being met. Continued process verification not only helps protect consumers from production faults, but business also see benefits in implementing a CPV program. Should product outputs not match target standards it can be very costly to investigate the problem source without existing CPV data.

The resources made available through this portal allow for manufacturers in the biopharmaceutical sector to respond to this guidance appropriately. They were created as a consensus view of an acceptable CPV program; they are not an exact representation of the internal policies of any contributing company. They are intended as a basis upon which companies in the BioPharmaceutical industry can build and share developing knowledge.

The authors believe this is a unique offering to the industry, wish all users well and welcome feedback.

* Process Validation: General Principles and Practices,guidance for industry, FDA (CDER, CBER, and CVM), January2011.


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