Stability (ICH Q1A) Quiz 3

Pharmaguidanaces Channel August 11, 2023 QA & QC, Quality Assurance, Quiz Comments Off on Stability (ICH Q1A) Quiz 3 255 Views

Stability (ICH) Quiz 3

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Stability (ICH) Quiz 3

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 combining data from several batches into one overall estimate?

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Question 2: When can a formal statistical analysis be omitted during stability data analysis?

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Question 3: Why should terms like "ambient conditions" or "room temperature" be avoided in labeling?

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Question 4: What should be displayed on the container label based on stability information?

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Question 5: What should be the basis for designing formal stability studies for a drug product?

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Question 6: When is photostability testing conducted for a drug product?

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Question 7: How many primary batches of the drug product should stability data be provided for?

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Question 8: What should be consistent between the primary batches and the proposed production batches?

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Question 9: What type of attributes of the drug product should be tested during stability studies?

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Question 10: How should analytical procedures used for stability testing be?

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