Having a CPV Plan brings you a lot of benefits! Benefits that include real-time monitoring of your products’ quality, an effective and consistent control strategy and signaling the discovery opportunities for process improvement.
You’d think that everyone would have implemented CPV Plans by now, but that’s not (yet!) the case. In this blog post, we’ll explore the reasons why this happens, and we’ll talk about how to set up a Digital CPV plan in only 3 steps.
What’s Holding Back Companies From Adopting CPV Plans?
Although FDA’s process validation guidance has been in place for a decade and all main regulatory agencies continue to highly recommend CPV program implementation, widespread CPV adoption is not yet a reality.
But, if we all have the guidelines, and if all agencies recommend CPV programs, what’s holding back their adoption? We think there are three reasons for this:
- Lack of data governance. Many manufacturers are still troubled by data integrity issues. Most organizations are dependent on contract CMO’s, and this can be quite a challenge as maturity level, data access, integration and governance differ from manufacturer to manufacturer.
- Difficulty gathering statistical and pharmaceutical expertise. This problem is not the problem itself, but it can lead to the use of inefficient data analysis methods for CPP and CQA’s. Also, the lack of advanced training on multivariate data analysis techniques delays the continued analysis of parameters and quality attributes in the CPV plan more efficiently.
- No integrated approach to managing data across development stages. The problem here is centered around data collection due to the manual handling of batch records. The synchronization of paper-based batch reports with electronic systems is something that takes a lot of time. Efforts to accelerate data collection can increase the possibility of missing data and compromise data integrity.
When you look at all these points together, it doesn’t come as a surprise that moving to a digital CPV plan could be the best solution for all.
However, many companies are postponing the digitalization of their processes. And they do this because of high costs.
Luckily though, the emergence of “big data” has been pushing companies towards digitalization and the gains in implementing a digital CPV from scratch or transitioning from a manual solution are considerable.
But how do you set up a Digital CPV Plan?
Setting up a CPV plan can be challenging, and one thing that can help you is taking a stepwise approach to ensure reproducibility and scalability. We recommend you set up a Digital CPV plan using this workflow that has three main steps:
Step 1. Critical Variable Definition
In this step, you’ll review the risk assessments that are performed based on the trends of data gathered in the CPV program. That’s where you will select critical variables that you will want to monitor.
Step 2. Reference Batch Selection
Then, you must select the best batch of the process. And for this, you should use a Multivariate approach! This method provides a solid statistical basis to account for system variability in the CQA, CPP and CMA spaces so they can be monitored and kept in a pre-defined state-of-control.
Step 3. Variable Configuration
This is where you can configure each variable included in the plan. And their configuration must consider different aspects such as:
- Types of statistical control.
- Approaches to ensure normal distribution.
- Process performance metrics (Cpk, PpK).
Important tip, add an alarm trigger approach to each variable! So, you will be notified whenever unexcepted process changes are detected.
And if you are Still not Convinced About the Benefits of a Digital CPV Plan…
You shouldn’t forget that this process can deliver a preventive behavior when something changes in your process. In addition, the real-time monitoring that defines this program enables your decision-making before final product quality is affected.
Also, it serves as a valuable input to the product quality review process, batch release decision, or change control procedures.
If you use this stepwise approach, we are sure that you’ll be able to aggregate all the historical information available, ensure data integrity and create a robust source of continuous improvement opportunities.
We can Help you With Your Digital CPV Implementation
If you would like to implement CPV in your processes, we can help you!
Our team will be more than happy to help you implementing a strong Digital CPV plan in your processes. Take a look at our services and don’t hesitate to contact us.