Hardware Podcasts

226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions

Let's Combinate · 11 Feb 2026 · 8m

What this episode covers

Subhi Saadeh, Founder of Let's Combinate, explains the ICH Q4 framework, which shifts the responsibility for pharmacopeial equivalence from sponsors to regulators via the Pharmacopoeial Discussion Group (PDG). He details how ICH Q4A establishes the harmonization process and Q4B provides the regulatory evaluation, specifically using ICH Q4B Annex 3(R1) on subvisible particulates as a practical example of method interchangeability. The episode highlights that while methods are generally interchangeable across ICH regions, specific conditions like the 100 mL nominal volume for parenteral products may require adherence to the most stringent criteria, such as those in the Japanese Pharmacopoeia.

Most relevant to

early-stage companies

Topics

Mentioned

Also
ICH, PDG, Japanese Pharmacopoeia, European Pharmacopoeia

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