Continued Process Verification (CPV) is the continued collection and analysis of data that assures your process is in a state of control. CPV Implementation is important because you can then monitor product quality in real-time. Efficiently.

In this blog post we write about why implementing a CPV plan in your process could be great for you. By the end of it, we hope you will be as excited about it as we are!

CPV, APR, Batch Releases. What is the connection between them?

First of all, if you want your CPV plan to be effective, you need to align it with other GMP procedures such as the Batch Release Testing (BRT) and Annual Product Review (APR).

However, while CPV works independently of BRT, that’s not the case with APR. Let’s go over why it is so.

BRT is the process where the products are tested, and whose results assure product quality is in accordance with GMP regulation and deadlines. Even though the CPV plan includes data related to BRT, the CPV data doesn’t impact any previously released lots.

When it comes to APR, things are different. CPV and APR work together. The APR is a high-level summary report of the processes’ performance. You can, therefore, fetch product data from the CPV and use the quality metrics in the APR report.

Let’s look at the regulatory context.

Now that we’re aware of the connection between these procedures, let’s move on to the next stop: understand the regulations that guarantee CPV’s compliance. And for that we’ll look at FDA’s regulations and the ICH guidelines.

Let’s start with the FDA Process Validation about what you need to consider for a CPV implementation:

  • First, the data collected from the program should contain critical information to the quality of both the inputs and the final product. And, of course, the process trends as they capture process current and future state.
  • Data needs to be analysed and reviewed by people with a statistical analysis’ background.
  • And, finally, all the collected data must confirm that the quality attributes are being properly monitored and controlled throughout the process.

That’s not all. It’s time to move to the second regulatory context: ICH Q8 and Q9!

The ICH Q8 is important because it presents CPV as an alternative method to process validation.

And on the other hand, ICH Q9 introduces the Quality Risk Management framework. This is important because the framework doesn’t just support the criticality assessment that is crucial to build a CPV plan. It goes beyond that because the CPV itself provides the evidence and metrics for Risk Review.

The conclusion is that the CPV implementation is highly recommended by regulatory authorities. It also means that it is one of the concepts included in the Quality by Design (QbD) framework.

But how does the CPV integrate with the QbD concept?

  • Supports the adoption of systematic approaches to quality risk assessment.
  • Ensures that the process is in a state of control.
  • Acquires knowledge for fact-based decision-making.
  • Consolidates product lifecycle management.

If all these points are meaningful to you, you should be ready to start implementing a CPV program in your process.

Time to discuss benefits and challenges

CPV Implementation is not linear. There are benefits and challenges. Let’s discuss them so that you understand whether it suits your process!

What are the benefits of CPV implementation?

The answer is a long and exciting list!

First of all, you need to keep in mind that CPV is all about delivering a much higher assurance and bringing excellence to your operations.

In addition to providing a continuous collection and analysis of critical data, a CPV program allows for a more efficient and complete control strategy. It will help you to identify sources of variability and be more effective at their monitoring.

And do you know what that means? A more robust and predictable process.

But, more specifically, what can you get from CPV implementation?

  • CPV will guarantee consistency in product quality and supply.
  • It will create a solid knowledge base for implementation of improvements throughout the product’s lifecycle.
  • CPV will create a higher level of trust near the regulatory authorities during inspections.

What about the challenges?

No implementation is flawless and CPV it’s not an exception!

However, we can separate the challenges based on whether CPV is implemented for new or legacy products.

When it comes to implementing CPV in new products, the main challenge is the lack of historical data which hinders the consolidation of process- and product-related knowledge.

On the other hand, if we are talking about legacy products, we have the opposite. Large volumes of process and quality data, that might also include non-relevant data. And besides that, in legacy products, there’s a large dispersion of the data in different formats across different platforms.

We can help your CPV implementation.

If you would like to implement CPV in your processes, we can help you!

We empower our clients with the iSEE Platform™. We choose it because it provides them with a stepwise approach to building a CPV plan.

This stepwise workflow relies on multivariate analysis for reference batches selection and provides a way to monitor the process in routine manufacturing. And in turn, this opens doors to process improvements, and supports risk assessments while reducing its subjectivity.

Have you imagined how faster and structured would be your monitoring program, both for innovative and legacy products? Take a look at 4TE services and don’t hesitate to contact us.

Related Topics

If you want to know how CPV can impact Risk Assessment Subjectivity, take a look here.