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Tablets & Capsules October 2020 19 integrated product development and regulatory submis- sions stage gate system, which I'll refer to as a stage gate system, or SGS, throughout this article. An SGS should offer you and your team a detailed roadmap to get from project initiation to post-approval commercial manufac- turing, no matter your dosage form. Features of a robust stage gate system Whether you plan to develop your own SGS or turn to an experienced partner to implement a system, know- ing how to recognize a well-planned SGS will serve you well. Here's what to look for: Quality is its core principle. If QbD is the objec- tive, then your SGS should be the playbook that shows you how to get there. The SGS that I've developed has six main stages, as shown in Figure 1, but that number can vary. What matters is the way your SGS champions quality from early feasibility discussions all the way to commercial process validation. It should define the roles, deliverables, and expected outcomes involved in each stage of your product development and regulatory sub- mission process. This gives you the benchmarks you need not only to assess and report on the quality attributes of your product, but to understand and improve the pro- cesses that shuttle the product through its R&D and com- mercial lifecycle. This is how quality gets done. It's designed to keep you nimble. As you progress through development, optimization, scale-up, transfer, and validation of your drug products, you need both con- trol strategies to ensure ongoing consistency and flexibil- ity to adapt to emerging opportunities to cut costs and improve quality. A strong SGS gives you both, balancing careful management strategies with the agility to accom- modate shifting variables such as product complexity, API availability, and evolutions in technology. It embraces collaboration. One of the key ways a well-executed SGS achieves QbD is in rethinking how able data to demonstrate the safety and efficacy of the final product. In a post-QbD world, however, the final product's quality isn't enough to win approval; regula- tors want to see data-driven risk management practices designed into every element of the drug development process, from project initiation through commercializa- tion. This challenges manufacturers to change the way they've always done things and embrace transparency and data-driven discovery. For companies that successfully adapt, the potential rewards of QbD are huge, long-lasting, and extend well beyond the obvious goal of regulatory approval. QbD principles can lead to improved cost control because you'll know your process inside and out and will be able to find leaks in your spending. You'll also be well-posi- tioned for rapid regulatory approval, increasing speed to market. Finally, you'll increase return on investment because you'll have systems in place to easily manage post-approval changes and ensure the quality and sustain- ability of your commercial process. Unlocking these rewards takes a flexible and modern strategy that harmonizes two critical elements of suc- cess: how you make your product, and how you prepare your regulatory documentation. I call this strategy an Figure 1 Sample product development and regulatory submission stage gate system Stage gate I Project selection & risk assessment Regulatory deliverable #1 Regulatory deliverable #2 Regulatory deliverable #3 Submission documentation to FDA Process validation report Stage gate II RLD characterization & prototype development Stage gate III Analytical method validation & scale-up formulation Stage gate IV Submission batch/bio batch manufacturing Stage gate V Regulatory submission Stage gate VI Transfer technology commercial manufacturing For companies that successfully adapt, the potential rewards of QbD are huge, long-lasting, and extend well beyond the obvious goal of regulatory approval.