Life Science Leader Magazine Supplements

CMO 2016

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Page 15 of 63

VALIDATION REGULATIONS LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 16 in January 2011 — is the fact it's an updated version of the original guid- ance on the subject … issued in May of 1987. (For the record, I was still in Mt. Carmel Elementary School.) The document states: "Since then [May 1987], we've obtained additional experience through our regulatory oversight that allows us to update our recommendations to industry on this topic." That's just shy of 30 years of accrued knowl- edge to update! Now multiply that by hundreds of drug manufacturers working with hundreds of CMOs to make sure we're all up to speed. Add that the guidance "aligns process valida- tion activities with a product life cycle concept and with existing FDA guid- ance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System," and we've entered into an interesting warp of pharmaceutical space and time. A VALID VALIDATION INTERPRETATION? Continuing our "travel" into this new realm, we can capture (with validated equipment, of course) discussions such as these (which take place at loca- tions such as Outsourced Pharma Conferences). Q: Interwoven within the guidelines from the FDA on process validation — now five years old — and the progression from Phase 1 to Phase 2 are concepts and approaches for technology transfer. How do these process validation guidelines apply and how often are they incorpo- rated into a tech transfer to a CMO? tion professional. In other words, it's "follow the guidelines" but elucidate case-by-case. Let's try to validate how it's working out. GUIDANCE FOR THE JOURNEY OF DISCOVERY Even if we who know little about process and product validation, if put in a room with such experts, we'd expect to hear (mind-bending) quality statistics, experience table- thumping analytical fortitude, and see charts, graphs, and schema of exacting science and statement. And indeed often within their meetings, you do get all of that. But we'd also get an earful of comments like "It's up to interpretation," "That depends," and my favorite, "Do we need to follow the guidance?" With no malicious intent — it all stems from a lack of knowledge on my part — but these experts of expected exactitude can sound more like weathermen predict- ing the veracity of the prevailing winds. The forecasts are currently centered around a piece of FDA advice entitled, "Guidance for Industry/ Process Validation: General Principles and Practices." Like the larger world of cGMP, documents drive discussion that leads to actual implementation. What adds to the "popularity" of this current document — first published t the same time, possessing the inquisitive qualities of the scientist and engineer, most of us also have an interest, to the extent possible and time permitting, in learning more about seg- ments outside our expertise. In a sense, this is a self-validation of who we are as individuals that collectively make up the pharmaceutical industry. In terms of individual careers — and despite a continuing trend overall toward specialization — I'd suggest that those most inquisitive about both their internal and external realms climb the highest. When we do venture into the science and technology, business strate- gies, tactics, and various challenges beyond our expertise and throughout the industry, we often find similarities with our own fields. One of these (rather amusing) simi- larities is that the "experts" aren't all that confident about the details of their own field. This can be experienced when wandering into another realm of validation, that of drug development processes, drug substance, and product. Here we encounter a field full of debate, some moving pieces, and comments such as, "It's up for interpretation." Perhaps the first thing we encounter is a realization that the FDA has simul- taneously laid both a heavy and light hand on the shoulder of the valida- Our industry is science-driven and technical, and we are overall a society of specialists. No one can understand in detail all that makes up the development, manufacturing, and commercialization of a specific drug. A By L. Garguilo A PROCESS VALIDATION — OF SELF AND SERVICE A Process Validation – Of Self And Service L O U I S G A R G U I L O Executive Editor, Outsourced Pharma @Louis_Garguilo

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