Industry news

How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 1

by Peter H. Calcott, NSF-DBA Consultant

Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. But many people in the industry are asking questions: How will it affect our process development programs? How will it affect the submissions and licensure of our products? And how will it aid in our commercial operations? Or will it have no effect?

Consider what the document says. In the simplest terms, it articulates four main messages. A strong process development program is essential — preferably using quality by design (QbD) — to eventually obtain expedited product approval and benefit from a relaxed regulatory position with the agency. Process validation (PV) is linked into that activity in verifying its conclusions: a set of team-based activities requiring many disciplines to work together to be effective. PV is value added and never stops. It requires a life-cycle approach with continuous verification and adjustment. (So continuous improvement is central to the activity.) By applying these principles, you will end up with a more reliable process that yields consistent products to meet your customers’ requirements, resulting in more satisfied customers. The overall take-home message is that PV is part of the drug development life cycle, that it never stops, and that it is a value-added activity. This can be described using what I call the “four Ds”:

• Design (build each process to a set of standards or requirements focusing on what a customer wants/needs)
• Demonstrate (by conducting experiments and validation to show that process and product meet design requirements)
• Document (the cornerstone of good work is recording it for posterity)
• Determine (ensure that results remain valid, or make changes as knowledge and experience grow — for continuous improvement).

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