In today’s fast-paced market, it seems as though there’s a new pharmaceutical product every day. With so many products making their way onto the scene at such a rapid pace, it’s essential that strict guidelines exist to ensure safety for end-users.
That’s where continued process verification (CPV) comes into play.
What is CPV?
The Food and Drug Administration (FDA) introduced CPV in the 2011 Process Validation Guidance and is a mandatory requirement for any company manufacturing products for human consumption. Its primary goal is to boost quality management and compliance within the industry. However, many have found it challenging to implement.
At its core, CPV is an official means to monitor the performance of manufacturing processes to ensure the end product’s strength, purity, and quality are not compromised at any point in production.
Diving deeper, CPV entails:
- Creating a written plan for monitoring the manufacturing process
- Analyzing results on a regular basis
- Documenting collected data
- Analyzing the data
- Taking any action needed based on the findings
Meticulous data collection and analysis are of the utmost importance as it helps identify any issues related to the product or process.
While CPV is a mandatory requirement, it’s also an excellent opportunity to evaluate your manufacturing process and discover areas for improvement. Companies can use CPV to boost product and process productivity, quality, and consistency.
It’s important to note that several aspects of CPV are known to overlap with existing GMP systems such as annual product review (APR) and change control.
How does CPV fit into process validation?
Essentially, CPV is a smaller part of the larger process validation picture.
There are three stages of Process Validation:
- Process design
- Process qualification
- Continued process verification (CPV)
While stage two largely focuses on the procedural aspects of manufacturing, like installation, operational, and performance qualification, stages one and three (CPV) involve more analytics and science-based approaches such as risk assessment and statistical process control.
CPV challenges
As previously mentioned, CPV doesn’t come without its challenges.
A major struggle companies face when executing CPV is determining what types and quantity of data they should collect and analyze. If you don’t make these decisions, you can risk either collecting too little data or collecting too much unimportant data. Too little data will leave you grasping at straws, and too much data can hide valuable data you’d like to use, as well as increase data interpretation costs.
Companies that use manual and non-standard processes may find themselves experiencing many challenges related to CPV implementation.
Many companies still rely on manual processes for activities such as recording data batches. When done by hand, there’s more room for inaccuracies. With so much data being recorded and analyzed, inaccuracies can cause delays and misinterpretations.
Another issue that stems from non-standard and manual processes is a general lack of data traceability. Collecting and filtering raw data is extremely challenging when employees complete everything by hand and record it on paper. And because it’s at the heart of CPV, the inability to easily access large amounts of data doesn’t bode well.
However, companies can resolve these issues by increasing their level of digitalization within their operations. While it can seem daunting, the benefits of digitalization outweigh the challenges.
Use CPV to your advantage
While CPV is a mandatory requirement, it can also open the door to opportunities that help companies create more robust, controlled manufacturing processes and find areas for improvement. Not to mention, create a better, more reliable end product.
Like many other regulatory aspects of the pharmaceutical industry, challenges are inevitable, and there’s no one-size-fits-all solution. However, with the right help, companies can not only meet CPV requirements but use it to usher in a new era of increased productivity, quality, and efficiency.
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