ICH Guidelines

ICH Q1A(R2) Stability Testing of New Drug Substances and Products

Stress testing, storage conditions, testing frequency, climatic zones and photostability requirements for new drug substances and products.

What this course covers

This course covers stress testing and long-term and accelerated storage condition requirements under ICH Q1A(R2), testing frequency expectations across a stability program's duration, climatic zone considerations for storage condition selection, and photostability testing requirements and when they apply.

Who this course is for

Stability program staff designing or executing stability protocols
Regulatory affairs staff supporting shelf-life and retest period submissions

What you'll learn

Stress testing and long-term and accelerated storage condition requirements under Q1A(R2)
Testing frequency expectations across a stability program's duration
Climatic zone considerations for storage condition selection
Photostability testing requirements and when they apply
How Q1A(R2) relates to shelf-life and retest period determination

Why it matters

Q1A(R2) is the foundational stability guideline that every other stability decision, including how an atypical result gets judged, ultimately traces back to. A stability program built on the wrong storage conditions or testing frequency compromises every result that follows.

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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