Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)

Regulatory Resource: Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)

Description:

This guideline has been revised a second time in order to accommodate for the consequences of Q1F and has reached Step 4 of the ICH process on 6 February 2003.

This guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimize the different storage conditions for submission of a global dossier.

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