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Continued process verification

 

Overview

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), January 2011.

News

Nov 2018

Continued Process Verification News

How to validate informatics in CPV programs

The BioPhorum Continued Process Verification (CPV) and Informatics team has published a paper to support a risk-based approach for the validation of[..]

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Nov 2017

Articles

Continued Process Verification delivering real saving in time and money

More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place.  Thanks to[..]

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Jun 2016

Articles

A roadmap for the implementation of continued process verification

This article provides a roadmap draws on the content of the CPV case study to provide a step-by-step guide in a more[..]

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Sep 2015

Continued Process Verification News

CPV team testing implementation approaches with CASSS

Since the CPV team published its seminal 100-page case study in 2014 (Continued Process Verification: An Industry Position Paper with Example Plan),[..]

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Dec 2014

Articles

Continued Process Verification

Our industry is embarking upon a significant change in the way we validate our processes and, although regulators have provided guidance documents,[..]

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Oct 2014

Articles

Continued Process Verification for Biopharma Manufacturing

The authors discuss complications of implementing continued process verification and provide recommended approaches.

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Jul 2014

Articles

BioPhorum ‘CPV’ collaboration tackles regulator guidance

BioPhorum has today published a Continued Process Verification (CPV) Case Study to help members of the biopharmaceutical industry implement high quality, consistent[..]

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