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May 2026
In this recap episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes.
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Welcome to the ISPE podcast, Shaping the Future of Pharma,
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where ISPE supports you on your journey,
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fueling innovation, sharing insights, thought leadership,
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and empowering a global community to reimagine what's possible.
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Hello and welcome to the ISPE podcast, Shaping the Future of Pharma.
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I'm Bob Chew, your host, and today we have another episode
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where we'll be sharing the latest insights and thought leadership
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on manufacturing, technology, supply chains,
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and regulatory trends impacting the pharmaceutical industry.
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You'll hear directly from the innovators, experts,
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and professionals driving progress and shaping the future.
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Thank you again for joining us, and now let's dive into this episode.
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Our topic today is Unlocking Innovation,
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Embracing Validation 4.0 for a Digital Pharma Future.
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To share more about this topic, I would like to welcome Michelle Vuolo,
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head of quality at Tulip Interfaces and co-lead of the Validation 4.0 guide team.
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And fellow guide team member representing South America
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is Victor de Oliveira Silva Ferreira,
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Project Manager for PEQMS, Implementation of Electronic Systems
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for the Quality Management System at the Instituto de Tecnologia
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Em Imunobiológico Fundação Oswaldo Cruz.
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Michelle and Victor, welcome to the podcast.
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We're so glad to have you both with us.
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Thanks. Thanks for having us.
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I hope that's a thank you for invitation.
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Well, first, before we jump into some of the questions about the guide,
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I'm curious, how did you guys get involved in this guide?
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What's your background? What's your passion? Why this one?
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Michelle?
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Sure. Yeah, I'll go ahead and start.
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Yeah, I work at Tulip Interfaces,
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which is a technology company providing software for manufacturing environments.
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I've been here about five years, but before that,
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I spent about 25 years in life sciences and doing all things quality
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from lab to manufacturing operations quality to all the way to IT quality,
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probably my natural progression and decided to get engaged
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with the Pharma 4.0 community of practice.
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And so I wanted to help modernize the way we look at quality and validation topics
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and thought that it would best fit in the Pharma 4.0 community of practice.
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So fast forward five years and lots of PE,
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pharmaceutical engineering articles and conference speaking
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and lots of really great active members in the ISPE community.
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Later, we published the good practice.
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And Victor?
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I have to work with qualification and validation for entire of my career,
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mainly with the development new strategies to release new products in my company.
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For the last five years, I was dedicated to understand
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how technology can enhance quality and validation strategies.
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So I joined in validation 14 and have been working with Michelle for these years in GPD.
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Well, great.
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Well, let's start out with kind of the big picture.
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What exactly is validation 4.0?
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Yeah, I can start because I do recall when we first got our working group
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now called subcommittee together.
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That was the big question.
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Like, what is it?
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Because validation is such a broad topic covering so many aspects.
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And it was very clear that it wasn't computerized system validation specifically,
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because there's Gantt for that very well established group.
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But that we wanted to look at how we could modernize validation
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and look at how to become more efficient and effective with validation
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in this digital world, right?
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Like, it doesn't have to be digital, but what's happening
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or what's driving the change to look at validation was the digital transition.
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And I think bigger picture even on that is really trying to help enable
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real-time validation, again, with the usage of digital technologies,
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real-time validation, continuous validation, looking at upstream and downstream
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sort of impacts on validation of what you're trying to validate.
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So it's sort of the bigger picture.
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It's rooted in the guideposts of the IEH guidelines,
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in particular quality risk management and quality by design
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to fundamental and foundational principles to enable validation.
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Really, when you look at validation as just like going back and saying,
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what is validation?
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It's really the demonstration of control.
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And so those are two fundamental principles and foundational aspects
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that need to be understood to really do validation on any focused way.
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Yeah.
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I don't like I did that.
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I see validation for is looking to data on the quality by design lens.
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So you need to ensure that the probability data
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is available for users during the entire life cycle.
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So there is an operational approach that approach itself.
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How do you need to do validation for?
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But there is an aspect, the business aspect regarding
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how you deal with validation quality as a business strategy,
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because it was discussed in years.
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Validation quality need to be work as business strategy
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to enhance control around the product process.
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So what triggered the creation of Validation 4.0?
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Was it the Pharma 4.0 good practice guide,
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or was it other factors in industry?
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Yeah.
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So, you know, we started working together as a group.
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There's, you know, there's an ebb and flow of folks
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that come and join on these groups,
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which is understood because people are volunteering their time to do this
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and have day jobs, so to speak.
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But, you know, I think our group was doing a lot.
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Like I said, we did a lot of
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pharmaceutical engineering magazine articles.
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We are trying to develop and define case studies.
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Then we moved on.
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We did a couple of presentations at most of the ISTE annual meetings,
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both in the EU and in the US.
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Also in the Eastern communities, too,
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because the co-lead of the Validation 4.0 working group is out of Bangkok.
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So we're able to do a lot of seminars and webinars out there in India as well.
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I'm forgetting.
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It's been five years.
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But then we got involved in one of the chapters,
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the quality chapter of the Pharma 4.0 baseline guide, right?
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So there's baseline guides, which are sort of higher level overarching,
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which is what GAMP is, for example.
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I think a lot of people with ISPE are very familiar with GAMP.
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And then under that umbrella,
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there's lots of good practice guides that are on specific topics.
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Like, for example, GAMP has an MES specific good practice guide.
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So, yeah, the Pharma 4.0 baseline guide was published in December of 23, I think it was.
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That's when we started saying,
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what are good opportunities for documenting more information
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on how to execute this Pharma 4.0 approach on particular topics?
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And so Validation 4.0 is prime for that.
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We've had our approach, our guideposts, our methodology defined.
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We've had a few case studies.
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So we started writing the good practice guide.
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And, you know, with the intentions of really trying to demonstrate to the industry
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how to do this more specifically than, you know, sort of this conceptual idea.
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If I go back many decades, there was an FDA aseptic process validation guide,
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if I recall correctly, talking about media fills or aseptic process simulation.
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And it specified a minimum of three lots.
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Now, in that case, one lot was at least 5,000 units.
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So you really were looking at the aseptic contamination possibility
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spread across 15,000 instances.
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But those three lots then kind of morphed into validation, process validation.
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And we need to do three lots.
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Now, we all would agree that three lots is not statistically significant
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and does not capture potential variability in raw materials and all this stuff.
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Now, up front, you're supposed to have development work
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that covers that base.
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And then you do these three lots.
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And then you do continuous process verification.
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Tell me how this validation 4.0 changes that.
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I can go first.
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And, Victor, jump in for sure if you want to help support or add anything different.
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But, yeah, so what we're trying to get away from in this validation paradigm
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towards a new paradigm is, you know, I think traditionally the three,
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you know, the tradition, the golden three-batch run,
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like that's always sort of like people immediately think of that
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when they think of, oh, how am I going to validate?
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What we're trying to do is shift the thinking away from,
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I have to do three runs of process validation
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towards how have I demonstrated the controls in my process?
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The only way to do that really is to understand your process requirements,
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which in my opinion are around quality by design, right?
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Quality by design, basically the fundamental of quality by design
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is the more you know about your product and process,
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the more you can control it, right?
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So the idea through CPP, CQAs, these critical aspects to your process
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are defined and identified as critical, right?
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Using your quality risk management principles
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and identifying the controls around each of those individually
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and developing controls around them.
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The validation of that is not just running through it three times.
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The validation of that is really building an evidence story
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around each of those controls and how you demonstrate them, really.
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So the idea is like the culmination of all these controls,
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the evidence of these controls really starts to become your validation package,
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not whether you ran it three times.
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You could have run it several times on, I don't know,
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different parameters and different things on a particular control area
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or a particular critical area of the process.
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But you're building this evidence file on an ongoing basis.
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If you can do this during product development, right?
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These iterations of like through risk management though, right?
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A controlled process of identify a risk and put a control in place,
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determining if it's effective or not,
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and iterating on that in this sort of continuous loop.
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That's where we also want to get into this continuous validation
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or the idea that we can, at any one point in time,
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understand our state of control.
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Yeah, we, using Go, said that we are going to move
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from the stage of validation to stage of validation.
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Because in the moment that we're starting,
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Go have control about the data since the development.
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You have confidence to scale up all validation activities
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through their all study, clinical studies,
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and to reach the commercial match understanding for the entire process.
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This is what you should know about holistic control strategy,
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is have all control for all strategies need to be implemented during the life cycle.
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Okay, you mentioned quality risk management.
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There's a lot of different views on that.
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There's a lot of different practices on that.
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I think those of us who have done it would agree that in most cases,
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certainly many cases, it's subjective.
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The probability, the effectiveness of the controls,
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and the probability given those controls, et cetera.
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How is validation 4.0 dealing with those,
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that subjective nature of quality risk management?
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And can technology turn subjectivity into objectivity?
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Yeah, I can go first or Victor,
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I want to give you the opportunity to go first if you want.
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Okay, I think that we are thinking validation 4
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in quality risk management.
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We are not speaking about using spreadsheets,
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but using digital tools to enhance the entire management.
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So, this allows to have capability to integrate systems with MERS,
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LIMS, and other kind of stuff to get data since the development,
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going through this system, provide the control.
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Obviously, there is some kind of complexity in doing this,
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but in the moment that you take quality validation group and IT group,
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look into the strategy of the whole process,
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you can provide control for all decision
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and activity that will occur in your manufacturing process.
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I believe this is the main point that quality risk management
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and validation can enhance.
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The possibility to, since the first time they start a process or product,
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you're working together to think,
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okay, what can affect my process, my product?
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How the sensor could be failed during my process
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and how this information put through quality risk management digital
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and send the trigger action that you can do in real time.
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So, these are, as I see, validation for enhancing quality risk management.
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Yeah, I think just to add to that too,
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is like one of the things that we have,
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like in all the presentations I've given on this,
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like one of the things we do say is like
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we are not prescribing a particular risk methodology at all.
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Like we're not saying FMEA is great or not or whatever.
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What we do, like what I do with myself
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and what I do like about ICHQNAN is risk identification,
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risk assessment, and risk control.
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Just logically that process works really well.
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And if you're doing a three-by-three matrix or a two-by-two matrix
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or you're using detectability or frequency or likelihood,
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we don't get into that level of detail.
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But what we're saying is we need to identify and understand
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the risk associated with certain data points, right,
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associated with your process.
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And so, and the idea is, again, as you are identifying the risk,
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you're like a sterility assurance,
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you identify the control, whichever it might be,
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and then you ultimately then verify the effectiveness of that control
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right away through several iterations or several runs.
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But the idea is that as soon as you get an effective or ineffective data point,
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that gets fed back into the risk,
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identified if the risk changes,
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which not often does the risk change itself,
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but the risk control is either effective or ineffective.
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And you determine if you need to adjust your risk control.
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So again, it's not a three-by-three matrix.
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It's not subjective or objective.
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It's, you know, the basis is product quality, patient safety always.
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So in those terms is where, again,
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that continuous loop allows you to feedback
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and adjust your controls as necessary.
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But again, I just think of many examples
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of having been in risk assessments in my previous life.
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And there is not that continuous loop.
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There's not that feedback loop.
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You know, we spend hours and hours and hours in a meeting room
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trying to determine the risk level of something
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and not really following up or understanding
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whatever control we put in place.
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Was it effective?
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Was it not?
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Did it impact other things?
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Like there's no assessment.
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And that is ultimately the most important piece.
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You know, coupling what Victor said is like in the digital world,
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digital is enabling us to do that more immediate feedback loop, right?
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And to look at things independently as well
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or look at individual controls as well,
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which I think is very important.
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This is, in my opinion, has not necessarily
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been done on a big scale until now.
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So risk assessments, as we just talked about,
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there's statistics behind them.
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They're probabilistically determined, right?
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It's a high probability.
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It's a low probability.
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There's a statistic to that.
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The concept of a design space assumes
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that you have some sort of statistical understanding
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of the interrelationships between different variables.
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Some of the relationships are strong,
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i.e. a high correlation coefficient.
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Some of them are weak, a low correlation coefficient,
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but it's statistics, right?
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Now, today we have AI,
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we have digital twins, process and equipment,
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and they're statistical tools, right?
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That's all they are.
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They're very sophisticated, but they're statistical tools.
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So we have a need over here from a design space
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and a risk assessment to have statistical analysis.
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And now we've got all these really cool tools
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that are statistical tools.
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How do we bring them together?
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Yeah, yeah.
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Well, so it was easy.
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Like one of my first things was like,
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oh, we just need digital risk assessment tools.
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And yes, that can help enable.
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Like I ultimately would like to see
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that some of these digital tools for risk management
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become validation tools, right?
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But even more importantly,
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and we have a few cases,
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I think we have two case studies in the guidance
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on utilizing a digital quality by design tool.
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What was really exciting about those case studies
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is that it was demonstrating the ability
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to use a digital quality by design tool to do that, right?
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And it was providing you the correlations
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between different control groups and different things.
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And it gave you the visibility or in a visual way
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about how like when you identify
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through quality by design,
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what's critical, what's not,
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what controls you put in place,
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and you can also link in what controls
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are impacting other critical aspects as well.
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But it provides you the ability
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to do statistical analysis
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on your control effectiveness as well,
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as you can plug in the evidence data
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after you execute this thing,
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you can determine whether those controls
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are effective or not,
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they might impact other things.
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So this is where we didn't wanna start
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with digital tools, right?
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Because we wanna get the fundamental aspects down,
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but we have a whole section on the main part
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of the document that's about enablers,
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digital tools and key enablers,
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which we feel like, yeah,
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if you wanna get to the state where we're,
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I don't wanna say promising,
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but the nirvana of this would be to get to the state
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of like just running continuously
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and being able to do a snapshot validation
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at any one point in time,
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you need to do that through digital tools, right?
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And I think the most effective ones
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that I have seen to date are,
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like I said, in the examples and the case studies
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on the quality by design tool that we used
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so that you could do that.
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So you could do the statistics
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so that you could see your effectiveness
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of controls in real time.
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So currently we've got three stages
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of validation, right?
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We've got what happens in development,
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then we've got the demonstration lots,
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and then we've got the ongoing.
359
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How does validation 4.0 change any of that?
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Or are they still those three phases?
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And will they ever change?
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My hope is yes.
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Do you wanna go, Victor?
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Yeah, I like to think that in validation 4,
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we are discussing about this stage of validation,
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thinking all in scalability.
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When you're looking for a new product,
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quality by phase appropriate is a tool
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to determine the level of effort
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that you need to put.
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But there is some difficulty to do
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in the paper-based way.
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So in the moment that you have control
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about all points of data,
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00:22:03,000 --> 00:22:06,000
all aspects, all risk in your process,
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you can escalate this control organically
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because you have digital tools to do that.
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00:22:13,000 --> 00:22:16,000
So I like to say that validation 4.0
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is about validation stage.
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I always consider that my process is validated,
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considering the level of the rigor of my phase.
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If my product goes to the phase one,
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to the phase two, I have control.
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And I know exactly what level of control
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I need to put because I have digital system,
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a digital ecosystem provide me visibility.
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How my strategy is going on
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and how this strategy can evolve
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uses the point to me.
390
00:22:47,000 --> 00:22:48,000
Yeah.
391
00:22:49,000 --> 00:22:52,000
Just on that, I heard an interesting quote
392
00:22:52,000 --> 00:22:54,000
and it's not direct word for word,
393
00:22:54,000 --> 00:22:57,000
but I'm reading the words a little bit.
394
00:22:57,000 --> 00:22:59,000
But the point was somebody asked
395
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at a conference I was at that said,
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00:23:00,000 --> 00:23:05,000
can we get from R&D to manufacturing,
397
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shift to research and design and manufacturing?
398
00:23:11,000 --> 00:23:13,000
I don't know if you appreciate
399
00:23:13,000 --> 00:23:14,000
the subtlety difference there,
400
00:23:14,000 --> 00:23:18,000
but the idea is that can we get from this state
401
00:23:18,000 --> 00:23:20,000
that's like, again, R&D is this whole thing
402
00:23:20,000 --> 00:23:22,000
and then there's this tech transfer
403
00:23:22,000 --> 00:23:24,000
and then there's this manufacturing space.
404
00:23:24,000 --> 00:23:28,000
Can we get rid of this zone in the middle
405
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where we're getting from research,
406
00:23:29,000 --> 00:23:33,000
really just beginning stages of quality by design
407
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to development and manufacturing as a stage, right?
408
00:23:38,000 --> 00:23:39,000
And this is, in my opinion,
409
00:23:39,000 --> 00:23:41,000
this is like, again, now you're speaking to Nirvana,
410
00:23:41,000 --> 00:23:44,000
but hey, we need a North Star here.
411
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Get to the state of just getting
412
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to these iterative cycles really early
413
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in the QBD process, right?
414
00:23:50,000 --> 00:23:53,000
So if you are starting,
415
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you've got the infrastructure in place
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to identify risks, identify risk controls
417
00:24:00,000 --> 00:24:02,000
and have a repository for,
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00:24:03,000 --> 00:24:08,000
or a place to capture evidence of control effectiveness
419
00:24:08,000 --> 00:24:09,000
and loop that back,
420
00:24:09,000 --> 00:24:11,000
very early in the process,
421
00:24:11,000 --> 00:24:14,000
it can be a design or a process development tool,
422
00:24:14,000 --> 00:24:14,000
in my opinion,
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00:24:15,000 --> 00:24:17,000
which means that you're just building evidence
424
00:24:17,000 --> 00:24:19,000
of your control file from the very beginning.
425
00:24:19,000 --> 00:24:24,000
I mean, in reality, you've got two control strategies.
426
00:24:24,000 --> 00:24:26,000
You've got process control strategy
427
00:24:26,000 --> 00:24:29,000
and contamination control strategy, right?
428
00:24:31,000 --> 00:24:33,000
For contamination control,
429
00:24:34,000 --> 00:24:38,000
that's somewhat molecule agnostic.
430
00:24:38,000 --> 00:24:42,000
It's strictly, are you filling vials
431
00:24:42,000 --> 00:24:44,000
or are you pressing pills, right?
432
00:24:46,000 --> 00:24:48,000
On the process side,
433
00:24:48,000 --> 00:24:50,000
yeah, they're different molecules.
434
00:24:50,000 --> 00:24:54,000
And once in a while, it's really different,
435
00:24:54,000 --> 00:24:59,000
but still the basic key parameters
436
00:25:00,000 --> 00:25:03,000
around pills or filling vials,
437
00:25:05,000 --> 00:25:06,000
I'm not saying they're the same,
438
00:25:06,000 --> 00:25:09,000
but there's certainly a whole science
439
00:25:09,000 --> 00:25:10,000
behind it that we understand.
440
00:25:11,000 --> 00:25:13,000
How could we not start
441
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from a blank sheet of paper every time?
442
00:25:16,000 --> 00:25:17,000
Yeah.
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00:25:17,000 --> 00:25:20,000
And how does validation 4.0
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bring in the lessons from other places?
445
00:25:25,000 --> 00:25:27,000
Yeah, I'm just giving you the term
446
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is maybe loosely adopted from pharma 4.0,
447
00:25:30,000 --> 00:25:31,000
but like plug and produce in a way,
448
00:25:32,000 --> 00:25:34,000
but in a very different sort of scope,
449
00:25:34,000 --> 00:25:37,000
but can you plug and play
450
00:25:37,000 --> 00:25:38,000
with different controls?
451
00:25:39,000 --> 00:25:42,000
Yes, it would seem like that, right?
452
00:25:42,000 --> 00:25:45,000
You're going to have to provide evidence
453
00:25:45,000 --> 00:25:48,000
for that on all of your products anyway.
454
00:25:48,000 --> 00:25:49,000
You're just going to have to, right?
455
00:25:49,000 --> 00:25:52,000
But can you plug in a control strategy
456
00:25:52,000 --> 00:25:58,000
for like pills or like vials
457
00:25:58,000 --> 00:26:00,000
or can you do that?
458
00:26:00,000 --> 00:26:02,000
It seems like, yes, with the digital world,
459
00:26:02,000 --> 00:26:03,000
you potentially could.
460
00:26:03,000 --> 00:26:06,000
Given the same parameters of X, Y, and Z,
461
00:26:06,000 --> 00:26:07,000
can you take your control
462
00:26:08,000 --> 00:26:10,000
and control evidence and plug it
463
00:26:10,000 --> 00:26:12,000
into a different product and process?
464
00:26:12,000 --> 00:26:12,000
It seems like you could.
465
00:26:13,000 --> 00:26:15,000
Obviously, there's nuances to that, of course,
466
00:26:15,000 --> 00:26:17,000
but like, again, just the infrastructure
467
00:26:17,000 --> 00:26:18,000
would be there.
468
00:26:20,000 --> 00:26:24,000
Yeah, I like I did that,
469
00:26:24,000 --> 00:26:25,000
but edition four, as I said,
470
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we said about data control of data,
471
00:26:28,000 --> 00:26:31,000
the next one is too much about data.
472
00:26:31,000 --> 00:26:33,000
There's several aspects
473
00:26:33,000 --> 00:26:35,000
in the requirements on X, Y, and Z
474
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saying that you need to evaluate
475
00:26:38,000 --> 00:26:41,000
all data for several control strategies
476
00:26:41,000 --> 00:26:42,000
in a holistic way
477
00:26:42,000 --> 00:26:43,000
because obviously,
478
00:26:43,000 --> 00:26:45,000
all pharmaceutical companies
479
00:26:45,000 --> 00:26:47,000
has on a certain level
480
00:26:47,000 --> 00:26:49,000
a contamination control strategy.
481
00:26:49,000 --> 00:26:51,000
But what an X, Y, and Z brings is
482
00:26:51,000 --> 00:26:54,000
we need to evaluate all these data.
483
00:26:54,000 --> 00:26:57,000
So validation for under this vision
484
00:26:57,000 --> 00:27:00,000
provide the tools and the approach
485
00:27:00,000 --> 00:27:03,000
to ensure that all controls,
486
00:27:03,000 --> 00:27:05,000
to ensure a serenity,
487
00:27:05,000 --> 00:27:07,000
ensure that there is no contamination
488
00:27:07,000 --> 00:27:10,000
in your facility is under control
489
00:27:10,000 --> 00:27:11,000
and evaluate together
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00:27:11,000 --> 00:27:12,000
several source of data.
491
00:27:14,000 --> 00:27:20,000
OK, are there any other new philosophies,
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00:27:20,000 --> 00:27:22,000
new approaches, differences
493
00:27:23,000 --> 00:27:24,000
that you would find
494
00:27:24,000 --> 00:27:26,000
in validation 4.0 guide
495
00:27:27,000 --> 00:27:29,000
versus the past practices?
496
00:27:30,000 --> 00:27:32,000
It's time for you to really show off
497
00:27:32,000 --> 00:27:33,000
the newness.
498
00:27:33,000 --> 00:27:34,000
What's cool?
499
00:27:37,000 --> 00:27:38,000
Do you want to go, Victor?
500
00:27:41,000 --> 00:27:42,000
OK, yeah.
501
00:27:42,000 --> 00:27:45,000
So I think what I started with is
502
00:27:45,000 --> 00:27:47,000
we didn't create quality by design
503
00:27:47,000 --> 00:27:49,000
nor did we create quality risk management,
504
00:27:49,000 --> 00:27:52,000
which are the fundamental key purposes.
505
00:27:53,000 --> 00:27:54,000
What we've tried to do is
506
00:27:54,000 --> 00:27:56,000
take an existing frameworks.
507
00:27:56,000 --> 00:27:57,000
Of course, we're not going to change
508
00:27:57,000 --> 00:27:58,000
the regulatory landscape.
509
00:27:58,000 --> 00:27:59,000
That's not our point.
510
00:27:59,000 --> 00:28:00,000
Or our objective.
511
00:28:00,000 --> 00:28:03,000
So we took the existing regulatory landscape
512
00:28:03,000 --> 00:28:05,000
and tried to articulate it
513
00:28:05,000 --> 00:28:08,000
in terms of where we are today,
514
00:28:08,000 --> 00:28:10,000
the capabilities that we have today.
515
00:28:11,000 --> 00:28:12,000
Also, I think the big piece
516
00:28:12,000 --> 00:28:13,000
is shifting the mindset away
517
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from methodology.
518
00:28:18,000 --> 00:28:20,000
I do, I say that because it's funny
519
00:28:20,000 --> 00:28:21,000
that one of the first questions
520
00:28:21,000 --> 00:28:22,000
that was asked was,
521
00:28:22,000 --> 00:28:23,000
what about the three runs
522
00:28:23,000 --> 00:28:25,000
of process validation, right?
523
00:28:25,000 --> 00:28:26,000
Always, because when you're talking
524
00:28:26,000 --> 00:28:27,000
to a validation person,
525
00:28:27,000 --> 00:28:29,000
that's immediately what comes to mind
526
00:28:29,000 --> 00:28:31,000
is three runs of process validation.
527
00:28:31,000 --> 00:28:32,000
And it's really starting to shift
528
00:28:32,000 --> 00:28:34,000
that mindset away from
529
00:28:34,000 --> 00:28:36,000
this sort of finite
530
00:28:39,000 --> 00:28:41,000
validation document package,
531
00:28:41,000 --> 00:28:43,000
which is, let's face it,
532
00:28:43,000 --> 00:28:44,000
it's a snapshot in time.
533
00:28:44,000 --> 00:28:46,000
It's a static thing, typically, right?
534
00:28:46,000 --> 00:28:47,000
That, oh, we might do it,
535
00:28:47,000 --> 00:28:48,000
redo it each year
536
00:28:48,000 --> 00:28:51,000
or some rendition of that.
537
00:28:51,000 --> 00:28:53,000
But what we need to start getting towards
538
00:28:53,000 --> 00:28:55,000
is a way, a methodology
539
00:28:55,000 --> 00:28:57,000
to start looking at these things
540
00:28:57,000 --> 00:29:01,000
sort of in uniquely
541
00:29:01,000 --> 00:29:02,000
and in real time.
542
00:29:02,000 --> 00:29:04,000
And the way to do that
543
00:29:04,000 --> 00:29:06,000
is through really rooting ourselves
544
00:29:06,000 --> 00:29:06,000
in the principles
545
00:29:06,000 --> 00:29:08,000
that are important to demonstrate.
546
00:29:08,000 --> 00:29:09,000
Again, I go back to
547
00:29:10,000 --> 00:29:13,000
demonstrating control, right?
548
00:29:13,000 --> 00:29:14,000
And if you ask any different
549
00:29:14,000 --> 00:29:16,000
validation experts,
550
00:29:17,000 --> 00:29:18,000
demonstrating control
551
00:29:18,000 --> 00:29:19,000
is probably not the first thing
552
00:29:19,000 --> 00:29:20,000
that they're going to say.
553
00:29:20,000 --> 00:29:22,000
Like, I've been around
554
00:29:22,000 --> 00:29:24,000
many validation people in my life
555
00:29:24,000 --> 00:29:27,000
and that word never really
556
00:29:27,000 --> 00:29:28,000
came up that often,
557
00:29:28,000 --> 00:29:29,000
which blew my mind
558
00:29:29,000 --> 00:29:30,000
when we started saying,
559
00:29:30,000 --> 00:29:31,000
what is validation?
560
00:29:31,000 --> 00:29:32,000
It really is about demonstrating control
561
00:29:33,000 --> 00:29:35,000
in the context of
562
00:29:35,000 --> 00:29:36,000
patient safety product quality
563
00:29:36,000 --> 00:29:37,000
at the end of the day.
564
00:29:38,000 --> 00:29:39,000
And so it's like really rooting ourselves
565
00:29:39,000 --> 00:29:40,000
in these principles,
566
00:29:40,000 --> 00:29:42,000
utilizing the requirements
567
00:29:42,000 --> 00:29:42,000
that are already out there.
568
00:29:42,000 --> 00:29:44,000
Again, I see HQ8, Q9,
569
00:29:45,000 --> 00:29:46,000
utilizing digital technologies
570
00:29:46,000 --> 00:29:48,000
because those are new capabilities
571
00:29:48,000 --> 00:29:48,000
we have now,
572
00:29:49,000 --> 00:29:52,000
new-ish, but new relative to,
573
00:29:52,000 --> 00:29:53,000
you know, previous approaches.
574
00:29:54,000 --> 00:29:55,000
And really getting ourselves
575
00:29:55,000 --> 00:29:58,000
into a state where we can determine
576
00:29:58,000 --> 00:30:00,000
and demonstrate validation in real time.
577
00:30:01,000 --> 00:30:02,000
This, in my opinion,
578
00:30:02,000 --> 00:30:03,000
will help us get to
579
00:30:03,000 --> 00:30:05,000
potentially quicker time to value
580
00:30:05,000 --> 00:30:06,000
on new products,
581
00:30:06,000 --> 00:30:07,000
but really also the evolutions
582
00:30:07,000 --> 00:30:08,000
of existing products,
583
00:30:09,000 --> 00:30:12,000
but also potentially taking account
584
00:30:12,000 --> 00:30:15,000
for upstream and downstream data, right?
585
00:30:15,000 --> 00:30:16,000
There's a lot of data out there
586
00:30:16,000 --> 00:30:16,000
we're not using,
587
00:30:16,000 --> 00:30:18,000
whether it's our raw material suppliers
588
00:30:18,000 --> 00:30:20,000
or it's real world evidence
589
00:30:20,000 --> 00:30:21,000
or whatever.
590
00:30:21,000 --> 00:30:22,000
Why does that not feed
591
00:30:22,000 --> 00:30:25,000
into our validation loop,
592
00:30:25,000 --> 00:30:26,000
our life cycle, right?
593
00:30:26,000 --> 00:30:28,000
Like now maybe in like
594
00:30:28,000 --> 00:30:29,000
annual product reviews,
595
00:30:29,000 --> 00:30:30,000
we might look at that stuff,
596
00:30:30,000 --> 00:30:31,000
but really as part of
597
00:30:31,000 --> 00:30:32,000
product and process
598
00:30:32,000 --> 00:30:34,000
and how that can help.
599
00:30:34,000 --> 00:30:36,000
Again, this is our North Stars
600
00:30:36,000 --> 00:30:37,000
trying to get to these places,
601
00:30:37,000 --> 00:30:38,000
but you got to get
602
00:30:38,000 --> 00:30:39,000
the infrastructure in place
603
00:30:39,000 --> 00:30:40,000
and the thinking
604
00:30:40,000 --> 00:30:41,000
and the cultural shifts.
605
00:30:43,000 --> 00:30:43,000
Victor?
606
00:30:44,000 --> 00:30:45,000
Michelle, it was perfect.
607
00:30:47,000 --> 00:30:50,000
Yeah, it was perfectly all sentence.
608
00:30:50,000 --> 00:30:52,000
So I believe this is the point
609
00:30:52,000 --> 00:30:54,000
that we shall stage,
610
00:30:55,000 --> 00:30:56,000
have control.
611
00:30:56,000 --> 00:30:58,000
There is a chapter in our guide
612
00:30:58,000 --> 00:31:00,000
that say that
613
00:31:00,000 --> 00:31:01,000
holistic control strategy,
614
00:31:01,000 --> 00:31:03,000
how you need to define
615
00:31:03,000 --> 00:31:04,000
this holistic control strategy,
616
00:31:04,000 --> 00:31:06,000
mapping the process,
617
00:31:06,000 --> 00:31:07,000
mapping the strategies,
618
00:31:07,000 --> 00:31:11,000
and how you can have this visibility.
619
00:31:11,000 --> 00:31:12,000
So this I think,
620
00:31:12,000 --> 00:31:13,000
this I believe is
621
00:31:14,000 --> 00:31:16,000
the core of the approach.
622
00:31:16,000 --> 00:31:18,000
Have control, have visibility.
623
00:31:18,000 --> 00:31:20,000
How this control is
624
00:31:20,000 --> 00:31:22,000
going through your process.
625
00:31:22,000 --> 00:31:23,000
Understanding in,
626
00:31:24,000 --> 00:31:25,000
how do you need to define
627
00:31:25,000 --> 00:31:28,000
a level of effort of activities
628
00:31:28,000 --> 00:31:31,000
to not to waste too much time.
629
00:31:31,000 --> 00:31:34,000
Because sometimes I have seen that
630
00:31:34,000 --> 00:31:37,000
there are a lot of work to do again,
631
00:31:37,000 --> 00:31:39,000
but if you have control of the data,
632
00:31:39,000 --> 00:31:41,000
mainly you can use to leverage
633
00:31:41,000 --> 00:31:42,000
previous knowledge,
634
00:31:42,000 --> 00:31:44,000
previous activities.
635
00:31:44,000 --> 00:31:46,000
So control is the fundamental
636
00:31:46,000 --> 00:31:47,000
of this approach.
637
00:31:47,000 --> 00:31:49,000
Have control of the data.
638
00:31:49,000 --> 00:31:52,000
Well, there's so many more dimensions
639
00:31:52,000 --> 00:31:53,000
that we could talk about
640
00:31:53,000 --> 00:31:55,000
for the next four hours.
641
00:31:56,000 --> 00:31:58,000
But to bring this
642
00:31:58,000 --> 00:31:59,000
to kind of a wrap up,
643
00:32:00,000 --> 00:32:03,000
I'm really excited about
644
00:32:03,000 --> 00:32:03,000
what's in this
645
00:32:04,000 --> 00:32:07,000
validation 4.0 good practice guide.
646
00:32:08,000 --> 00:32:11,000
What I see when you talk about
647
00:32:11,000 --> 00:32:12,000
quality by design
648
00:32:12,000 --> 00:32:14,000
and quality risk management
649
00:32:14,000 --> 00:32:16,000
as being the fundamentals,
650
00:32:16,000 --> 00:32:18,000
and then demonstrating
651
00:32:19,000 --> 00:32:23,000
that your controls are effective,
652
00:32:23,000 --> 00:32:23,000
that they work.
653
00:32:26,000 --> 00:32:28,000
To me, that's what
654
00:32:28,000 --> 00:32:30,000
the regulators have been
655
00:32:30,000 --> 00:32:32,000
wanting us to do all along.
656
00:32:33,000 --> 00:32:35,000
But we've kind of been
657
00:32:35,000 --> 00:32:37,000
shackled by past practices.
658
00:32:39,000 --> 00:32:42,000
And I'm hopeful that this document
659
00:32:42,000 --> 00:32:44,000
helps us move towards
660
00:32:44,000 --> 00:32:46,000
where the regulators
661
00:32:46,000 --> 00:32:47,000
really want us to be.
662
00:32:49,000 --> 00:32:50,000
And hopefully shed
663
00:32:51,000 --> 00:32:54,000
some non-value-added practices
664
00:32:54,000 --> 00:32:57,000
that we thought we had to do
665
00:32:58,000 --> 00:32:59,000
along the way.
666
00:33:00,000 --> 00:33:01,000
And really get us to where
667
00:33:01,000 --> 00:33:04,000
we're always evaluating the data
668
00:33:04,000 --> 00:33:06,000
as it comes in, in real time.
669
00:33:08,000 --> 00:33:09,000
Maybe even making adjustments
670
00:33:09,000 --> 00:33:11,000
without regulatory approval
671
00:33:12,000 --> 00:33:13,000
based on data.
672
00:33:13,000 --> 00:33:15,000
Yeah, I agree.
673
00:33:15,000 --> 00:33:16,000
I can't agree with you more.
674
00:33:16,000 --> 00:33:18,000
And you've summarized it really well.
675
00:33:19,000 --> 00:33:21,000
And just one little anecdote is,
676
00:33:21,000 --> 00:33:22,000
we did work with
677
00:33:22,000 --> 00:33:24,000
a quality innovation group
678
00:33:24,000 --> 00:33:24,000
out of the EMA.
679
00:33:24,000 --> 00:33:26,000
And that was really an exciting process
680
00:33:26,000 --> 00:33:28,000
that they were so willing
681
00:33:28,000 --> 00:33:29,000
to spend the time with us
682
00:33:29,000 --> 00:33:31,000
to review our concepts.
683
00:33:31,000 --> 00:33:33,000
And they had some great input
684
00:33:33,000 --> 00:33:34,000
and that did ultimately
685
00:33:34,000 --> 00:33:35,000
get into the guide.
686
00:33:36,000 --> 00:33:38,000
But I think they were excited.
687
00:33:38,000 --> 00:33:40,000
They were excited because
688
00:33:40,000 --> 00:33:40,000
they're like, this is what
689
00:33:40,000 --> 00:33:41,000
they've been trying to push
690
00:33:41,000 --> 00:33:43,000
for Annex 15 for so long.
691
00:33:44,000 --> 00:33:47,000
And there's wording in there,
692
00:33:47,000 --> 00:33:48,000
in the Annex 15 already,
693
00:33:48,000 --> 00:33:50,000
it states continuous validation
694
00:33:50,000 --> 00:33:51,000
and all these kinds of things.
695
00:33:51,000 --> 00:33:53,000
And it pushes the principles.
696
00:33:53,000 --> 00:33:54,000
And I think they thought
697
00:33:54,000 --> 00:33:56,000
that maybe this will help
698
00:33:56,000 --> 00:33:58,000
also push the industry
699
00:33:58,000 --> 00:34:00,000
to adopt something that, again,
700
00:34:00,000 --> 00:34:02,000
has been out there for a while now.
701
00:34:02,000 --> 00:34:04,000
Well, that brings us to the end
702
00:34:04,000 --> 00:34:07,000
of another episode of the ISPE podcast,
703
00:34:07,000 --> 00:34:09,000
Shaping the Future of Pharma.
704
00:34:09,000 --> 00:34:12,000
A very big thank you to our guests,
705
00:34:12,000 --> 00:34:13,000
Michelle and Victor,
706
00:34:13,000 --> 00:34:16,000
for sharing how Validation 4.0
707
00:34:16,000 --> 00:34:19,000
will help industry apply technology
708
00:34:19,000 --> 00:34:20,000
to improve quality,
709
00:34:21,000 --> 00:34:22,000
reduce cost of goods,
710
00:34:22,000 --> 00:34:25,000
and perhaps even speed time to licensure.
711
00:34:26,000 --> 00:34:27,000
Please be sure to subscribe
712
00:34:27,000 --> 00:34:30,000
so you don't miss future conversations
713
00:34:30,000 --> 00:34:32,000
with the innovators, experts,
714
00:34:32,000 --> 00:34:34,000
and change makers
715
00:34:34,000 --> 00:34:35,000
driving our industry forward.
716
00:34:36,000 --> 00:34:38,000
On behalf of all of us at ISPE,
717
00:34:38,000 --> 00:34:40,000
thank you for listening.
718
00:34:40,000 --> 00:34:41,000
And we'll see you next time
719
00:34:41,000 --> 00:34:44,000
as we continue to explore the ideas,
720
00:34:44,000 --> 00:34:46,000
trends, and people
721
00:34:46,000 --> 00:34:51,000
shaping the future of pharma.
