Improving Control: Contracting and Quality’s Middle Ground

Jan. 19, 2009
Pharma contractors face a delicate challenge in maintaining their own rigorous quality standards while encouraging the same of both clients and suppliers. Fran DeGrazio, VP for Marketing and Strategic Business Development at West Pharmaceutical Services, has worn many hats during her long tenure at West, and shares her thoughts on Quality by Design, sound sourcing, and leveraging IT for quality and compliance efforts.

Fran DeGrazio

PhM: FDA and ICH have both come forward with initiatives geared towards quality systems. How much influence do they have in West’s operations now?

F.D.: For any companies that are market leaders in the pharma industry, many of these things that FDA and ICH have talked about are already being done, already being implemented as part of their standards or as part of continuous improvement. 

From the FDA standpoint, good manufacturing practices, cGMP’s for the industry as a whole, are something we've been doing at West for years. We need to be cGMP compliant as a key supplier to the pharma and device industry. That's something that we’ve had in place.

When you talk about ICH, and when you look at Q8, Q9, Q10, they're really pulling together some of the thought processes around quality systems as a whole and saying, "How do all these activities work together?" And that's from a development standpoint, all the way through the manufacturing processes. 

PhM: Is there any one area that you may have been focusing on more in the last couple years as it's become apparent that it might more important than you previously thought?

F.D.: Sure. One of the things that I can say that we're focusing on more going forward is the whole concept of a design space and Quality by Design. That's something we're looking at in our own organization: how do we implement those ideals within our development and manufacturing process? But, also, how does what we do as a supplier impact our customers? And how can what we do then fit into their development or their Quality by Design program within their organization?

I can talk about is a new product called VeriSure that we introduced in November of 2007. VeriSure products are closures that are certified for extractables. Whether it is, for instance, a stopper that may be used on a vial, or a syringe plunger that could used in a syringe system, we're able to provide two parts: one is a technical package of information that a customer could purchase, which has all the extractable information about that formulation. The other portion of the program is where, on a lot-to-lot basis, that product is controlled and tested for extractables. 

How this fits into our customers' Quality by Design scheme is that it's evident when you look through the ICH and FDA guidances that they're looking for controls. Our customers push their controls upstream because the control upstream allows for less variation in their pharmaceutical and biotech manufacturing processes. VeriSure provides a product that is the ultimate as far as chemical consistency. 

PhM: One of the aspects of Quality by Design is that it is something that goes beyond your immediate organization and is passed on to clients on one end or suppliers on the other. Would you consider your Quality by Design initiatives to be proactive initiatives that you've done because you knew that they would become important for your customers?

F.D.: Right, absolutely. In the case of VeriSure, it really is an industry-leading product. VeriSure is giving the pharma customer an additional assurance that what they used in their development and clinical studies and what they use five years down the road has a consistent extractables profile.

PhM: And have you seen more inquisitiveness on the part of your customers, in terms of something like extractables?

F.D.: Sure, we do at times. Typically, if everything is rolling along fine, you don't have those inquiries that often except during development. But if we go out to the industry—and occasionally we must go out with a customer notification, saying that one of our raw materials may have been impacted or there's a change that we're notifying them of—then you'll start to get more inquiries from customers. 

But one of the key things from West’s standpoint that is unique is the long-term relationships we have with many of our suppliers.

Our suppliers understand why change control is so important to us, because we work with them to understand any changes or to be told about any changes. The long-term relationships that we have with them have been beneficial to us with the kind of market that we serve.

PhM: You mentioned that long-term relationships are really essential if you're going to have a good relationship with a supplier and really know what's coming from them, and being able to ask them questions. With your own suppliers, have you tried to find out more about what they're doing these days? Have you been trying to find out more where their materials are coming from, exactly what practices they're using to produce their materials?

F.D.: Sure. With materials that we've been using for an extended period of time, we usually have a very good, very sound background and history on those materials.  Quite often West has had more knowledge about some of the raw materials than some suppliers, because there are no pharmaceutical-grade rubber raw materials. Quite often, the raw materials that we use are the same raw materials that are used for the tire industry or electronics industry. So in some cases we know significantly more about the materials themselves, and we've even worked with our suppliers to put certain testing programs in place. Certainly, as new suppliers come around, and as many of these raw materials are considered commodities and are made by alternative sources, our base knowledge of raw materials becomes extremely important. If we are looking at off-shore production sites for raw materials, we can bring a lot of our knowledge to bear in qualifying our sources.

PhM: How much, within reason, can you know what's going on with your suppliers' suppliers, and be comfortable that the materials that your suppliers are getting are sound?

F.D.: Well, again, how far back in the chain do you go? Our supply chain group certainly tries to work on that, but I can't tell you that we have an infinite knowledge of our suppliers' suppliers’ sources. We have intimate knowledge of our suppliers' process and what they're using to qualify and what they're using to release materials to us. So from that standpoint, the materials are very controlled.

PhM: And who, or what body, at West would be overseeing that kind of information?

F.D.: That's a combination of our quality assurance group with our analytical labs, along with our supply chain organization.

PhM: What IT developments have you been pursuing, and how do your suppliers fit into that development?

F.D.: We've made significant investments in IT. From a quality management standpoint, over the last three years we've been implementing TrackWise as a system to help us manage customer complaints, corrective and preventative actions, and other quality processes. 

In addition to that, we are right in the midst of rolling out both a new MES system, Werum, for the manufacturing plants and are also in the midst of rolling out SAP in North America. We've successfully rolled out the first phase of SAP, the order system sales functions. The second phase that we're going through now will be in the manufacturing facilities themselves.

PhM: What have been the most difficult parts of this sort of IT overhaul, if you want to call it that?

F.D.: It has gone, I think, extremely well compared to some horror stories that we've heard. I think the main thing was getting the commitment from operations, and striking a balance between implementing these major IT systems and continuing to run the operation. There are certainly business people that need to be involved in the IT implementation. But then, at the same time, these people also help to run the operation itself. So that's probably the greatest challenge. 

But I think that we had a lot of people that understood the reasons for moving in this direction, and have given it their all-out effort to make sure that it's been successful.

PhM: And what aspects of your IT infrastructure, then, are you extending out to either your own suppliers or your own clients and customers?

F.D.: I don't know enough detail on the SAP side to tell you—that’s the supply chain portion where that connectivity comes into place—but what I can tell you is, on the customer side of things, we're about to roll out updated customer portals, what we're calling Customer Corner. And that will be for our top one-hundred customers. 

With SAP, that will give us the ability to allow customers on-line access to certain reports at any time. For example, we may have a situation where once a week our customer service representatives would push an open order report to a customer, and by the next day it was different. Now, with this Customer Corner capability, our customers can log on and view that report anytime they'd like. 

Over time, we're hoping to be able to add features that would be specific to that customer within the customer portal. 

PhM: Was the SAP decision just done completely on West's own doing, or were clients actually suggesting that SAP would be a good system to have to integrate with?

F.D.: Yes, it's West that made the decision. We knew that we needed to upgrade our systems and one of the main reasons for going with SAP was we wanted to have a global system. . . .

PhM: You have had regulatory responsibilities for West in the past. How much have these systems helped from a compliance perspective?

F.D.: Fortunately, we were very strong from a compliance standpoint, but a lot of our systems were, from our IT standpoint, older systems. What that meant was that, quite often, we had to review and double review and do triple verification of certain things to ensure compliance.

With SAP, any of the areas that need to be are being fully validated.  That's probably the most substantial difference with the IT systems going to SAP. With the validated systems we will not have to do double and triple verifications. 

PhM: I don't know a whole lot about the background of your laboratory solutions business. Can you just fill us in briefly?

F.D.: We started the laboratory service in 2000. One of the things that West prides itself on is being able to identify and come up with solutions to help our customers, to help facilitate what they're doing and make them successful. 

An issue we were hearing from our customers through the late '90s was that they were struggling with extractables and leachables testing because it was something that historically wasn't an issue, but the regulatory agencies weren't approving a lot of applications. They were saying, "Have you looked for what could be coming out of the packaging into your drug product?"  Our customers didn't know where to start, so that's why they came to us. We developed the analytical lab service in response to our customers' need.

We've grown and expanded the business. We can supply extractables and leachables testing and a wide variety of drug product and delivery system testing.

About the Author

Paul Thomas | Senior Editor