CPV versus APR, What’s the Difference?

June 29, 2016 by Fred Wiles, Sr. Process Optimization Consultant

On the Blog: In recent years, we have seen a growing trend to establish formal Continued Process Verification (CPV) programs. However, we are learning that there is much confusion in the industry over the differences between CPV and the Annual Product Review (APR) process.

As an outcome of the 2011 Food and Drug Administration Process Validation Guidance, there has been ever increasing interest in the pharmaceutical industry to establish formal Continued Process Verification (CPV) programs for manufacturing processes. There is, however, much confusion over the differences between CPV and the Annual Product Review (APR) process. Most pharmaceutical companies already do some form of trending as part of their APR process. I often get the question, “We already have Annual Product Review in place, why should we go to the trouble of implementing a CPV program?” Annual Product Reviews are just that – annual. A CPV program allows reacting to trends as they occur in real-time. Detecting and correcting unwanted trends or shifts real-time promotes control of the process, reduces waste and maximizes product quality. Allowing as much as a year to go by before detecting and correcting trends and shifts can result in costly recalls and regulatory action.

APR programs typically include some form of data trending, but this trending is usually highly summarized and consists of merely plotting process data on a run chart with specification limits. CPV, on the other hand, is much more involved. In addition to monitoring processes real time or nearly so, CPV monitoring also includes the use of control charts with calculated control limits to signal when a process may be going out of control. Unlike run charts, control charts utilize statistical process control concepts to determine when observed variation in a process exceeds what would be expected for a stable process; that is, a process that is in a state of statistical control. CPV also serves as a valuable input to the APR process. Because data collection and analysis of production data is done on an ongoing basis, there is no need to scramble at the end of the APR reporting cycle to collect and analyze data. Product data can be sourced directly from the CPV database and summarized as needed for inclusion in the APR report. As well as being a regulatory expectation, Continued Process Verification provides a mechanism to react to process shifts and trends in real time in contrast to Annual Product Review (APR) where as much as 12 months may pass before detecting a change in process performance. While there are similarities between CPV and APR, CPV should not be thought of as APR. CPV should serve as a key input to APR where a high level summary of process performance is reported on an annual basis. Fred Wiles, Sr. Process Optimization Consultant Published June 29, 2016 Learn more about ProPharma Group’s Process Validation services. Contact us to get in touch with our subject matter experts for a customized presentation.

It is with great pride that we are pleased to announce that ProPharma Group has successfully completed 15 years in business! On behalf of our colleagues, we would like to take this opportunity to thank our clients and partners for your continued trust and support.

During this journey, we have continued to develop our business and expand our services to meet the needs of our clients. We have worked with companies of all sizes, from start-ups to the biggest brands in the industry, and have met a multitude of wonderful people along the way. It is these relationships that have fueled our continued growth.

ProPharma Group began in 2001 with 2 employees in Kansas City, Missouri. Now we will be celebrating our 15-year anniversary with nearly 600 colleagues across the United States, the United Kingdom, and Australia. ProPharma Group recognizes and appreciates that our continued success is a result of the caliber of our clientele and ongoing referrals.

Looking forward, we are committed to our constant determination to improve not only in the work we do, but also remaining in sync with the ever-changing healthcare industry.

We take this opportunity to thank you for your loyalty. We look forward to many years together.

As an outcome of the 2011 Food and Drug Administration Process Validation Guidance, there has been ever increasing interest in the pharmaceutical industry to establish formal Continued Process Verification (CPV) programs for manufacturing processes. There is, however, much confusion over the differences between CPV and the Annual Product Review (APR) process. Most pharmaceutical companies already do some form of trending as part of their APR process. I often get the question, “We already have Annual Product Review in place, why should we go to the trouble of implementing a CPV program?” Annual Product Reviews are just that – annual. A CPV program allows reacting to trends as they occur in real-time. Detecting and correcting unwanted trends or shifts real-time promotes control of the process, reduces waste and maximizes product quality. Allowing as much as a year to go by before detecting and correcting trends and shifts can result in costly recalls and regulatory action. APR programs typically include some form of data trending, but this trending is usually highly summarized and consists of merely plotting process data on a run chart with specification limits. CPV, on the other hand, is much more involved. In addition to monitoring processes real time or nearly so, CPV monitoring also includes the use of control charts with calculated control limits to signal when a process may be going out of control.

Unlike run charts, control charts utilize statistical process control concepts to determine when observed variation in a process exceeds what would be expected for a stable process; that is, a process that is in a state of statistical control. CPV also serves as a valuable input to the APR process. Because data collection and analysis of production data is done on an ongoing basis, there is no need to scramble at the end of the APR reporting cycle to collect and analyze data. Product data can be sourced directly from the CPV database and summarized as needed for inclusion in the APR report. As well as being a regulatory expectation, Continued Process Verification provides a mechanism to react to process shifts and trends in real time in contrast to Annual Product Review (APR) where as much as 12 months may pass before detecting a change in process performance. While there are similarities between CPV and APR, CPV should not be thought of as APR. CPV should serve as a key input to APR where a high level summary of process performance is reported on an annual basis.

 

Latest Posts

Data Integrity: 5 Ways to be GxP Compliant
September 14, 2018

Are you always ready to be inspected for your (GxP) activities in your facility? Is…

Read More Computer Systems Validation

Related Posts

Contact Us