ICH Guidelines

New ICH Q1 2025 Draft - Stability Testing: What's Changing?

Why ICH is consolidating Q1A through Q1F and Q5C into a single revised Q1 guideline, and what to prepare for now.

What this course covers

This course covers why ICH is consolidating the Q1A through Q1F stability guidelines and Q5C into a single Q1 document, what is expected to change in storage condition and testing frequency requirements, how the draft addresses continuous manufacturing and real-time release testing, and where the new Q1 draft affects biotechnological products previously covered separately by Q5C.

Who this course is for

Stability and regulatory affairs staff planning ahead of the final guideline
Anyone managing a stability program for both small-molecule and biotechnological products

What you'll learn

Why ICH is consolidating the Q1A through Q1F stability guidelines and Q5C into a single Q1 document
What is expected to change in storage condition and testing frequency requirements
How the draft addresses continuous manufacturing and real-time release testing
Where the new Q1 draft affects biotechnological products previously covered by Q5C
What sites should do now to prepare before the guideline is finalized

Why it matters

A consolidated Q1 guideline will be the biggest change to stability testing expectations in years. Sites that understand the direction of the draft now can start aligning their stability programs before the final version forces a scramble.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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