Let's Combinate - Pharma + Medical Devices with Subhi Saadeh10 Kesä

241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework.

Rather than reviewing the guideline section by section, this episode focuses on the ideas that are most useful in practice:

Why does ICH Q14 start with the Analytical Target Profile (ATP)?

How is it different from ICH Q2?

How do you develop analytical procedures using a science- and risk-based approach?

And what does all of this have to do with ICH Q12 and lifecycle management?

One quick note: at the time of recording, ICH Q14 remains under public comment, so some details may evolve before the final version is adopted.

Chapters

00:00 – Intro and ICH Q14 vs. Q2

01:08 – The Analytical Target Profile (ATP)

04:16 – The Analytical Procedure Lifecycle

05:32 – Risk-Based Development and Enhanced Approaches

06:20 – Where ICH Q2 Fits: Validation

08:04 – Connecting Q14 to ICH Q12 and Lifecycle Management

09:22 – Closing the ICH Quality Series

In this episode, we cover:

• Why ICH Q14 exists

• The difference between ICH Q14 and ICH Q2

• What an Analytical Target Profile (ATP) is

• ATP examples and performance criteria

• Technology selection and fit-for-purpose methods

• The analytical procedure lifecycle

• Risk assessments and enhanced development approaches

• Multivariate experiments and DOE concepts

• Analytical procedure control strategies

• Validation and the role of ICH Q2

• Lifecycle management of analytical procedures

• The connection between ICH Q14 and ICH Q12

• Why understanding matters more than simply checking a box

If you've followed along through the ICH Quality series, one of the themes that keeps showing up is that quality isn't something you test into products at the end. Whether we're talking about Q8, Q9, Q10, Q12, or now Q14, the emphasis continues to shift toward building knowledge, understanding risk, and using that understanding throughout the lifecycle.

Subhi Saadeh is the Founder and Principal at Let's Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, speaker, and host of the Let's Combinate podcast, with experience across companies including Pfizer, Gilead, and Baxter supporting vaccines, biologics, generics, and combination products.

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#ICHQ14 #ICHQ2 #ICHQ12 #AnalyticalValidation #PharmaQuality #QualityByDesign #LifecycleManagement #DrugDevelopment #CombinationProducts

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