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Let's Combinate - Drugs + DevicesAuthor: Subhi Saadeh
Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating! Language: en Genres: Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
Wednesday, 4 February, 2026
In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substances and drug products.Subhi explains what impurities are, why zero impurities is unrealistic in scalable manufacturing, and how ICH Q3 establishes a risk-based framework to protect patient safety and product quality. The episode walks through the structure of Q3A through Q3E, covering impurities formed during drug substance synthesis, degradation in drug products, residual solvents, elemental (metal) impurities, and extractables and leachables highlighting where drug delivery systems and combination products explicitly come into scope under Q3E.This episode is a high-level, practical overview focused on how to read ICH Q3, how the sections fit together, and where the guideline applies and stops across the drug product lifecycle.⸻Timestamps00:00 Welcome to Let’s ComBinate00:12 Introduction to ICH Q300:25 What Are Impurities and Why They Matter00:51 Sources of Impurities and Risk-Based Control02:11 Structure of ICH Q3 (Q3A–Q3E)05:30 How to Read and Use ICH Q307:22 Q3E, Extractables & Leachables, and Drug Delivery Systems09:21 Wrap-Up and Next Episode PreviewSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
