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.