Stability (ICH Q1A) Quiz 1

Stability (ICH) Quiz 1 The purpose of this note is to outline the changes made in Q1A(R) that result from
adoption of ICH Q1F “Stability Data Package for Registration Applications in
Climatic Zones III and IV”.


Stability (ICH) Quiz 1

ICH Stability Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II. 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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Question 1: Which regions are covered by the stability data package defined as Per ICH guideline?

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Question 2:  What is the purpose of ICH guideline regarding stability data?

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Question 3:  What environmental factors are considered in stability testing?

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Question 4:  Why is stress testing of the drug substance important?

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Question 5:  What environmental factors should stress testing include?

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Question 6:  How many primary batches of the drug substance should have formal stability studies conducted?

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Question 7:  Where should the stability studies be conducted for the drug substance?

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Question: 8: What is the recommended frequency of testing for drug substances with a proposed re-test period of 12 months?

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Question: 9: When is increased testing recommended for accelerated storage conditions?

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Question: 10:  What purpose do the storage conditions serve in stability testing?

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The average score is 62%


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