Hardware Podcasts

235 - ICH Q8: How Pharmaceutical Development Actually Works

Let's Combinate · 22 Apr 2026 · 10m

What this episode covers

Subhi Saadeh, founder of Let’s ComBinate, explains the structure and practical application of ICH Q8 (Pharmaceutical Development), a guideline for harmonizing regulatory submissions. He details how to define the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) to build quality into the product by design rather than testing it in. Saadeh describes establishing a 'design space' through risk assessment and Design of Experiments (DoE) to define acceptable ranges for material attributes and process parameters. Finally, he outlines how this knowledge informs the control strategy and the organization of data within CTD Section 3.2.P.2.

Most relevant to

established companies

Topics

Mentioned

Companies
Let’s ComBinate
Also
ICH Q8, CTD Section 3.2.P.2, ICH Q12, ICH Q9, ISO 13485, FDA 21 CFR 820.30

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