Tuesday , September 26 2023

Stability (ICH Q1A) Quiz 4

Stability (ICH) Quiz 4

QA -

Stability (ICH) Quiz 4

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: What is the purpose of conducting stability testing on a drug product after constitution or dilution?

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Question 2: What does "significant change" for a drug product typically involve?

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Question 3: When should a commitment be made to continue stability studies post approval?

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Question 4: Under what circumstance is a post approval commitment considered unnecessary?

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Question 5: If the submission includes stability data on fewer than three production batches, what additional commitment is required?

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Question 6: What happens if significant change occurs at the accelerated storage condition on commitment batches?

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Question 7: What should be consistent between the stability protocol for commitment batches and the primary batches?

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Question 8: What should be consistent between the stability protocol for commitment batches and the primary batches?

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Question 9: Under what conditions can testing on commitment batches be conducted at the intermediate storage condition?

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Question 10: What attributes of the dosage form might be considered in stability testing?

Your score is

The average score is 41%


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