In our recent blog post we talked about the benefits and challenges of Continuous Process Verification (CPV) Implementation. We hope you’re convinced! This time we want to talk about how to do a CPV Implementation.
CPV implementation requires that, first, you use a well thought logic and rationale that we call workflow! Second, that you decide whether you do it online or offline. But let’s go over it!
Using a Workflow
If you want to implement a CPV program that is both reliable, compliant, explainable, and scalable to the rest of your company, then you should use a workflow!
There are three steps for this CPV workflow:
- Critical Variable definition
- Reference batch selection
- Variable configuration
Critical variable definition
The first step is meant to define how critical the variables are. The purpose? You want to make sure you include the Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) in your CPV Plan.
And, to get this, you need to perform a risk analysis. Once you figure out both the CQAs and CPPs, you need to monitor them.
We recommend that, for this purpose, you use a Risk Management platform. Ideally, this platform will allow you to make the risk assessment based not only in information but also in data.
Reference batch selection
In this step, you need to use a multivariate approach in order to select the best and most representative batches. You want to account for the system variabilities of the CQAs, CPPs and CMA spaces.
By doing this, you make sure that the starting statistics are solid and representative of the process. And that gives you a pre-defined state of control.
And this leads us to the variable set up. We have three steps for that.
You begin by creating Statistical Control Charts. First, each CQA, CPP and CMA needs a chart. And then you need to keep in mind other aspects such as:
- Approaches you should take to reach a normal distribution
- What metrics to include (average, standard deviation, specification limits, etc.)
- Types of Statistical Control Charts (Shewhart, cumulative sum, etc.)
Now, besides the Statistical Control Charts, you can monitor other metrics within a CPV plan. For example, metrics related to process capacity, such as the Process Capability Index (CpK) or the Process Performance Index (PpK).
Last, but not the least, if you’re using an online version of CPV, you can define alarm triggers to help you take decisions quickly. You set them up by building a decision tree that triggers respective alarms whenever there is a statistical deviation.
Using CPV Online
An Online CPV tool has many benefits when compared the offline counterpart. Some of those benefits are:
- Data Integration. Online CPV allows you to integrate system and process data according to the needs of your CPV Plan.
- Data Acquisition. With Online CPV you keep an automatic and more precise data collection when compared to doing it manually.
- Automatic metric updates. Your system will automatically update the process capability metrics as well as the control charts.
- Alarm triggers. The system will let you know if something is not going well.
- Reporting. Creating and producing reports that meet your requirements for OpEx, Compliance and Regulatory QA usage. Fully aligned with your PQS systems.
All of this can be put together in one sentence though: Effortless process monitoring and control.
We can help your CPV implementation.
If you would like to have CPV implemented in your processes, we can help you!
We empower our clients with our iSEE Platform™, the de-facto CPV environment.
It is a game-changer and differentiator since it provides the user a stepwise approach to build a CPV plan and associated workflow.
This workflow relies on multivariate analysis for reference batches selection and provides a way to monitor the process in routine manufacturing, which opens doors to process improvements, and provides data to support 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.
Do you have interest in CPV programs development? We recommend you the reading of another blog posts.