The success of a globalisation strategy relies on a key pillar: process and product performance comparability. This is so because global pharma companies require flexibility to produce the same product across a network of manufacturing sites and locations. For this blog post, we’re going to offer our perspective on how to handle this key challenge of global pharma and support global manufacturing of pharma products.
A very global challenge
A globalised pharma company will have several manufacturing sites that expand their capacity and technological flexibility.
There is a problem though. How do you make sure that the product is the same independently of the site and location?
Manufacturing the same product in separate locations can be challenging. Among the challenges that you face, you may find:
- different equipment or different equipment setup
- raw materials properties and their supply chains that are not exactly the same
- transfer of explicit and tacit knowledge between teams
- local environment conditions
This results in that the product manufactured in the new location, that was meant to be the “same product”, is not really the same product.
Product effectiveness and process comparability are a major concern of regulatory agencies. As such, you need to be equipped with a body of knowledge support these processes.
So, the challenge is: how do we guarantee product performance when the conditions are necessarily different?
A digital solution to support global manufacturing of pharma products
We have one solution in mind.
You can face this challenge using a Digital CPVs connected to a central platform under a comparability framework. But how does this work?
Before anything else, we’re imagining this process using a bi-dimensional approach. There’s a focus on the process and the product in one site, but we’re also looking at all the sites at the same time.
For this, we need an integrated platform encompassing three essential pillars: real-time monitoring, global connection, and global benchmarking.
First of all, by using a Digital CPV, that changes in the paradigm in process and quality control.
You move away from a reactive stance which historically has been based on testing quality in the product and doing the CPV analysis based on product testing results. Instead, you take a proactive stance where real time data allows you to act upon the process continuously. And this aligns with the true nature and purpose of CPV.
This real-time monitoring opens up a series of possibilities. For this specific case, it gives you the capacity for proper and timely diagnosis of real-time deviations as well as troubleshooting and establishment of CAPAs.
By having multi-point CPV programs along key points in your process, you can acquire meaningful real-time CPP data. This enables your teams on the shopfloor to draw conclusions on the quality of the product in production before each critical point. By monitoring key steps in the process, you can know whether the product aligns with the Quality Target Profile.
Which is great by itself. But when you put it together with the other piece of the puzzle it becomes amazing. That next piece is global connection.
If you inter-connect all your sites under the same system, you can actually compare the CPPs and CQAs from all the different sites.
Which means two things. First, you can learn from the data and transform data into knowledge, and you can benchmark the data continuously. And you can benchmark it across your process and across your multiple sites, ensuring that the drug is consistently identical, independently of what site or location your product is made!
At 4TE we see the approach to Digital CPV and Comparability as a major opportunity. More than quality control and process lifecycle monitoring it’s also the path towards ideal global manufacturing.
The gains for global pharma are so substantial that we went ahead and developed our proprietary software, iSEE PlatformTM.
If you think we can help your business, whether global or not, through Digital CPV implementation, take a look at our service page.
More of our work
If you’d like to know more about the benefits of a Digital CPV, check this blog post of ours.