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CMO 2016

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 18 VALIDATION REGULATIONS A: We just went through that. We were actually very happy in terms of the discussions we had with the regulators. We were trying to utilize two different sites as part of the commercialization process. One was at a CMO where we had done all the clinical fills, and then the other was an internal site for full com- mercialization production. The discus- sions with the agency on the strategies for validation actually ended up being very good. THE VALIDITY OF IT ALL To bring us back from this journey of validation, and in case you are looking for some firmer ground to again stand on, we can end with a more direct inter- pretation of the state of this field. A: Validation guidances are near and dear to me. I practically sleep with this FDA document under my pillow. It's five years old now, and in many meet- ings and discussions with the FDA, I've learned the agency indeed takes it for granted that the industry has already fully adopted at least this new validation paradigm. A: So much so, that a lot of the FDA's focus has already moved on to the qual- ity metrics side of the equation. I've been in quite a few discussions with sponsors, CMOs, and the FDA, and the question often comes up, "Is this process validation really required or is this just a recommendation?" A: Well, if you just read the opening pages of the new quality metrics draft guidance, the authors make it quite clear that they view the process validation paradigm as a requirement . It's an aspect of GMP. I've been surprised by what a strong stand they've taken. Frankly, I like seeing that. I think it makes good business sense that sponsors and CMOs look at it as more than just a compliance requirement. I do not think it's optional to adopt the new validation guidance. So there. Perhaps it is a more "settled science." Now it's back to the actual document for more interpretation. At least for some of us. Best wishes. L for. You should be able to prove that intent to the FDA. For example, there are four or five different ways you could do a careful, low-risk and high-work maintenance vali- dation, with strong documentation and an intensive experimental scale-down/ scale-up process for a compound … or you can do the bare minimum to conserve early funds as interpreted within FDA guidelines, as long as you are in discus- sions with the FDA as to what you are doing and your objectives. A: If it's a product expected to progress very quickly, perhaps meeting unmet medical needs, from the side of the FDA, it would probably move faster through process validation than if it's a follow- on biologic. Although the standards for validation aren't relaxed by inspectors, the extent of testing and monitoring may be reduced. If a company has a fast track, and they're willing to take higher risk, they're probably going to minimize the work versus a company with a low-risk tolerance that needs everything to happen right the first time. Yes, to answer your question, there is a high level of variability on how process validation is done and can be approved by the regulatory bodies. A: Agreed. You'll get six different answers, if you ask that question of six different people. Obviously we all know this, but particularly nowadays, you should start your interactions with the regulators as early as possible. Chances are they will have requested some addi- tional characterization of your product and process at some stage during the development of your molecule anyway. And you definitely should have your CMOs involved in all of this. A: I think many find that this type of coordination and interaction actually leads to pleasant surprises. There are some flexibilities that the agency will provide. They're not going to be very liberal, so to speak, but on some points, depending on the data that you have and can generate, you could propose certain strategies, which include a very high level of product characterization, to make the agency comfortable. A: It very much depends on who the customer is. If it's a virtual customer, with one person tasked with this activ- ity, such as what I'm currently doing at my company, there aren't subject matter experts. You're relying on the CMO to be doing most of the work on implementing the proper validation protocols. For this type of sponsor, it helps substantially to maintain the same CMO, as long as they have a proven track record, when moving your compound from Phase 1 to 2, and even more so from Phase 2 to 3. A: Conversely, if you're a large pharma with strong technical support and subject matter experts, it'll probably work much differently. You'll be pre- scriptive about what you want and drive protocols. So from a validation perspective, there will be less of an issue if the decision is to change CMOs between stages. Q: If I understand your answers cor- rectly, it depends upon the customer and it depends upon the company size when deciding process validation. Is that to say that throughout the industry we're not uniformly implementing the FDA guidelines for validation? A: Well, you could ask the same question about GMPs. There's not a checklist say- ing, "This is exactly what I need to do." It's following the intent of what's being asked By L. Garguilo A PROCESS VALIDATION — OF SELF AND SERVICE The FDA has simultaneously laid both a heavy and light hand on the shoulder of the validation professional.

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