Stability (ICH Q1A) Quiz 2

Stability (ICH) Quiz 2

quiz 1 scaled -

Stability (ICH) Quiz 2

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:  How long should the long-term stability testing cover for at least three primary batches?

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Question: 2:  What temperature and relative humidity are used for accelerated storage condition testing?

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Question: 3: Which intermediate storage condition is applicable when long-term studies are conducted at 30°C ± 2°C/65% RH ± 5% RH?

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Question: 4: How is "significant change" for a drug substance defined?

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Question: 5: What storage condition is recommended for drug substances intended for storage in a refrigerator?

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Question: 6: What temperature is considered for long-term storage of drug substances intended for storage in a freezer?

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Question: 7: How are drug substances intended for storage below -20°C treated?

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Question: 8: What is the purpose of making a stability commitment post approval?

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Question: 9: Under what condition is a post approval commitment considered unnecessary?

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Question 10: How the degree of variability of individual batches is related to the confidence in future production batches?

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The average score is 51%


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