Tuesday , September 26 2023

Stability (ICH Q1A) Quiz 5

Pharmaguidanaces Channel August 11, 2023 QA & QC, Quality Assurance, Quiz Comments Off on Stability (ICH Q1A) Quiz 5 122 Views

Stability (ICH) Quiz 5

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Stability (ICH) Quiz 5

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 can be done to combine data from multiple batches for an overall estimate?

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Question 2:  Under what circumstances can limited extrapolation of real-time data be done to extend shelf life?

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Question 3:  What assumption is made during extrapolation of real-time data for extending shelf life?

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Question 4:  Why should terms like "ambient conditions" be avoided in storage statements?

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Question 5:  What should be displayed on the container label based on stability evaluation?

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Question 6:  What is the purpose of accelerated testing in stability studies?

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Question 7:  What kind of storage conditions are used in accelerated testing?

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Question 8:  What is the concept of bracketing in stability testing?

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Question 9:  When is bracketing applicable in stability testing?

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Question 10 :  What does the term "Commitment batches" refer to?

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