Explore every episode of the podcast Manufacturing Made Simple Podcast

Current GMP under 21 CFR Parts 210 and 211 governs pharmaceutical manufacturing. Cosmetic GMP has historically been voluntary — and is becoming mandatory under MoCRA. Andrew explains the practical differences, why validation and documentation requirements are significantly more demanding on the pharmaceutical side, and what manufacturers serving both markets need to understand.

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The regulatory arc generates the highest question volume of any topic in the series. Andrew answers listener questions on MoCRA timelines, EU registration, the sunscreen monograph situation, OTC transition strategies, and adverse event reporting obligations.

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EU Cosmetics Regulation No. 1223/2009, the European Medicines Agency framework, ICH harmonization guidelines, and the challenge of building a global regulatory strategy across multiple overlapping frameworks. Andrew explains how to think about global compliance architecture before — not after — you decide which markets to enter.

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NDAs, ANDAs, and the 505(b)(2) pathway — Andrew explains the FDA's pharmaceutical approval framework, why the clinical trial system works the way it does, how the OTC Drug Review monograph system was modernized under the CARES Act, and why the CMC section of any regulatory filing is where manufacturing quality meets regulatory strategy.

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The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to US cosmetic regulation in nearly a century. Andrew explains its four pillars of facility registration, product listing, mandatory adverse event reporting, and forthcoming GMP regulations as well as what each one means operationally for manufacturers.

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Five more listener questions spanning formulation decision-making, the difference between contract and toll manufacturing, pharmaceutical IP protection, what clean beauty actually means from a regulatory standpoint, and how a personal care brand can move into producing their own OTC drug products.

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Every formula must satisfy three constraints simultaneously: efficacy, safety, and cost. Andrew explains how to navigate the trade-offs between all three in real product development decisions — including what "true cost" in formulation actually means beyond ingredient spend, and why safety is a hard constraint, not a variable.

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Every formula must satisfy three constraints simultaneously: efficacy, safety, and cost. Andrew explains how to navigate the trade-offs between all three in real product development decisions — including what "true cost" in formulation actually means beyond ingredient spend, and why safety is a hard constraint, not a variable.

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The pharmaceutical companion to Episode 3. Andrew covers active pharmaceutical ingredients, critical quality attributes, excipient selection across solid, liquid, and parenteral dosage forms, and the concept of bioavailability — the metric that connects formulation science to clinical reality.

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Andrew answers the first batch of listener questions and shares some insights to first had experiences he has seen.

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What's actually IN your shampoo, lotion, cleanser, and serum? Andrew breaks down core ingredients of emollients, humectants, surfactants, active ingredients, and explains what each one does.

Personal care and pharmaceuticals aren't two separate worlds but are really more like two points on the same line. In episode 2, we walk through where these industries converge, where they diverge, and why that distinction matters more than most people realize. From shared manufacturing principles to unified quality and regulatory thinking, this episode breaks down how these two industries mirror each other in ways that surprise even seasoned professionals.

Whether you work in the space or you've ever picked up a product off the shelf and wondered how it got there, this one's for you!

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In this first episode, host Andrew Cheung shares why he started Manufacturing Made Simple after 15 years working in quality and regulatory on both the manufacturing and brand sides, he's seen too many avoidable mistakes and too much gatekeeping of knowledge. He talks about what the show will cover, who it's for, and what to expect every week. If you've ever wondered how the products on your shelf actually get made and what goes wrong along the way, this is your show.

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