Tuesday , September 26 2023

Stability (ICH Q1A) Quiz 6

Pharmaguidanaces Channel August 11, 2023 QA & QC, Quality Assurance, Quiz Comments Off on Stability (ICH Q1A) Quiz 6 154 Views

Stability (ICH) Quiz 6

quiz 2 -

Stability (ICH) Quiz 6

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 a "Container closure system" in pharmaceutical terminology?

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Question 2:  What does the "Expiration date" of a drug product represent?

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Question 3:  What are formal stability studies used to establish or confirm?

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Question 4:  Which type of stability studies are undertaken to determine the shelf life of a drug product?

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Question 5:  What is the main characteristic of impermeable containers?

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Question6:  What is the purpose of intermediate testing in stability studies?

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Question 7:  What does the concept of mass balance involve in stability studies?

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Question 8:  What does the mean kinetic temperature represent in stability studies?

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Question 9:  What is considered a new molecular entity for stability testing purposes?

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Question 10 : What is a pilot scale batch in the context of drug manufacturing?

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