Ask the Expert: Collaboration Ensures Effective Procurement

To ensure the long-term success of a drug product, pharmaceutical manufacturers integrate procurement, manufacturing, and quality departments early in the development process to ensure material reliability and regulatory compliance from clinical trials through commercialization, according to Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Effective procurement is not merely about finding the lowest-cost materials; it requires a clear communication channel between several key departments. R&D and manufacturing teams must establish detailed specifications and grades (e.g., for microcrystalline cellulose) rather than simply requesting a generic ingredient. The involvement of the quality assurance (QA) department ensures that suppliers meet good manufacturing practice expectations. QA is responsible for verifying that materials are made to the right standards, often through audits or by reviewing certifications from industry organizations. Finally, by understanding the product lifecycle, procurement can investigate the long-term availability of specific material grades and identify commercially viable suppliers for the future.

How does collaboration ensure quality and mitigate risks?

Using substandard or incorrect grades of materials during clinical trials can lead to significant setbacks. If a company uses a material in early trials that is later found to be unsuitable for large-scale manufacturing, they may be forced to redo research and development. For startups and entrepreneurial firms, these delays can lead to a total loss of funding before the product ever reaches the market.

As a product moves toward commercialization, the supply chain must adapt to changing needs. Early development requires small amounts of high-grade materials, while commercial production requires much higher volumes that may only be available in different grades or from different suppliers.

The handover between Phase II and Phase II clinical trials is a critical point for reassessing the supply chain. This is often when larger companies take over, potentially shifting production to different geographic regions like Asia or America, necessitating a new risk assessment.

To secure the supply chain, manufacturers should ideally qualify backup suppliers to hedge against the risk of a primary supplier going under.

In this episode of the Ask the Expert video series, Sue and Siegfried, answer the question:

“My company is developing a new drug product. What departments in our company should we involve in materials procurement to maintain a reliable supply chain for the lifecycle of the product?”

About the experts

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of PharmTech’s Editorial Advisory Board.

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of PharmTech’s Editorial Advisory Board.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to PTProjects@mmhgroup.com, and it may appear in a future episode or print column.

We hope you enjoy the discussion!

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Sue Schniepp. I'm a Distinguished Fellow with Regulatory Compliance Associates, which is a division of Nelson Labs. And with me is Siegfried Schmitt. And Siegfried I'll let you introduce yourself. Thank you. Sue Siegfried Schmitt, Vice President technical with PAREXEL consulting, and together with Sue we are answering questions to ask the expert. And so today we got another question in

it says, My company is developing a new drug product, excellent. So what departments in our company should we involve in materials procurement, so we're making sure that we get all the right materials to maintain a reliable supply chain for the life cycle of the product. So very clearly that person is thinking not just about the moment now, but the whole life cycle. So perhaps, so you would like to start with giving an answer to that. I really like this question because, like you said, Siegfried, this person is thinking ahead. So they're not just going to go with whatever purchasing puts in front of them. They're going to investigate it. And I think that's a critical issue that they're talking in the purchasing arena, which usually isn't involved in these types of decisions. They kind of, you know, somebody says, I need micro crystal and cellulose. And purchasing goes out and gets some.

This person is thinking of sustainability through the life cycle of the product, so they're willing to kind of do that outreach and get purchasing to procure the right grade, the right requirements of that inactive ingredient that they're wanting to use in the formulation of the product. So I think that's really telling that is one area we forget about, is procurement. And I think it's really great that this person is thinking along those lines. There's so many ways to go here, so I'm going to let you go some down another path, Siegfried.

Well, as you say, Sue procurement needs to know what they should be procuring. So, as you said, maybe just micro cellulose. But of course, there are many grades, and so someone in manufacturing, maybe someone in development needs to put together the specifications, and it's these specifications that need to be shared with procurement.

So there has to be a communication channel between the various departments in the company that may not necessarily be established yet, or maybe it's not really clear, there may not be a process, a process flow for who is telling procurement from the manufacturing side or the development side, or maybe even the quality control, laboratory side, what needs to be procured. That is one thing, but with that, we also want a particular quality, a particular specification. So you may not only want the product, you may also want to have certain testing done by the company you're buying your materials from. So there is more to just handing over a piece of paper and say, Please get me the cheapest microcellulars that you can get. And we just need half a kilogram of this. So that's that's not enough of a specification, I'd say,

I think so. Best Practices involves the procurement and purchasing department, because the last thing that you want to do is run your clinical trials. This is more your area of expertise than mine, but you want, you don't want to be using a substandard micro crystal and cellulose in your clinical, clinical trials, and then have developmental issues as you're trying to establish the requirements to go into manufacturing for once the products approved, right? You don't want to step back and have to re do research and development all over again, because you didn't spend the time upfront to involve purchasing and procurement to get the right grade of material in the first place. That happened so many times, where companies just set themselves back on their timeline and and in some cases.

Because they're entrepreneurial or startups, we lose the product we don't have. You know, the product never does make it to market because the funding runs out, right?

As we said at the beginning, so this person that sent in the question is thinking ahead. And of course, in the early stages of development, you need small amounts, and they may be available in very high grade qualities. Whereas if you're looking to the future because you want to bring your product to market, then you have much, much higher volumes, and your material may only be available in a different grade of quality. So you not only that, maybe you have to go to different suppliers. Maybe one supplier only provides high, high grade, small amounts, others may provide a different grade, much larger amounts. So it you really have to have a conversation with procurement about what is available, what may be available, because it may well be that at the moment, no one is thinking about providing this particular grade in a large volume, but if it is commercially viable, they may be willing to provide it to you in future. So there

again, as we say, we need to have conversations, and these conversations are not just between the development team the production team, but it's also the quality team, because in the end, of course, you are likely to get a certificate of analysis from the provider of the material, but you can't just rely on that. You have to perform certain tests when you receive your materials. And that, again, is your expertise, so isn't it? Yeah, yes, it is. And I kind of want to lead us You said something very critical in the beginning, and that was about GMP expectations. So even though you're in the development side of or the clinical trial material side, you still need to ensure that the purchase, the people you're purchasing, whatever grade micro, crystalline cellulose or whatever inactive ingredient do meet GMP standards You can't buy the you know, cheapest is not always the best. And purchasing and procurement want to involve quality in those that decision just as much as quality wants to involve them. Because quality is going to have to go in and take a look at the manufacturer of the material to make sure that they are making GMP grade material. I think that's kind of, you know, critical there. I'm glad that you mentioned that, because I'd almost kind of forgotten it's not just about, okay, here's our specs, here's what quality wants, here's what R and D want. It's also about and can they make it under GMP conditions.

And as you said, someone at the company has to verify that not only the material is the right material, the right quality, but it's also made to the right standards. And if you think about many of the companies that develop new products, many of them are small and medium sized companies, so they may perhaps not have the resources if they even have all the know how what needs to be done to ascertain whether this these companies do the right thing. So not so,

especially when we think about excipients rather than the active pharmaceutical ingredients. So a lot of these manufacturers wouldn't really let you into an audit, but many of them actually provide certificates that they are producing to the relevant standards. May be IPEC. IPEC is one of these organizations that helps with these programs, but still ultimately, it is always the responsibility of the manufacturer that all the materials used are of the right quality.

So perhaps coming back to what you said about quality assurance, so how should quality.

Insurance be involved in all these procurement activities, I agree, and when the last thing, I kind of want your opinion, because I don't really know where to go with this. It's kind of difficult when you're securing the supply chain. You always kind of want to hedge your bets to make sure that

you have a backup supplier. So I think an early stage of development, it's hard to kind of, you know, qualify two suppliers for the same material. I mean, when does that ideally? When do you ideally do that? When you pass, you know, phase one, I don't know. It's kind of one of those weird questions I've always had.

Well, I think we could look at what typically happens in industry. Quite a large number of companies will take a product up to and including phase two clinical trials, because that is typically a financial involvement that can be managed once it comes to phase three trials. We are talking about very big money, and that requires, typically larger companies. So there is a handover, typically between phase two and phase three clinical trials, and certainly at that point, it is prudent to reassess the supply chain. What are their materials? Where are they coming from? Because even now, when you have this handover, you see, your development company may be sitting in Europe, but the company that will take it to market may be sitting in Asia

and or in America, for example. So they may perhaps want a slightly different supply chain. They may have a different risk assessment about the supply chain. So again, what we are looking at is a life cycle. So nothing is really, really constant over the years when the product is being developed and the materials are being purchased. I mean, I just read in the papers about some of the ingredient suppliers in Germany that struggle to stay afloat, that are really struggling to make a living these days. So even in well established companies may go under at some point, and you may have to change your supply chain, your suppliers.

Wow, and maybe that's another topic for our next as the expert, how do you change suppliers without disrupting your supply chain or your to market, the product to market. Wow, that was great. Thanks. Siegfried, always pleasure to talk with you. Thank you. Sue Totally agree. We should