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Stability (ICH Q1A) Quiz 7

Pharmaguidanaces Channel August 11, 2023 QA & QC, Quality Assurance, Quiz Comments Off on Stability (ICH Q1A) Quiz 7 388 Views

Stability (ICH) Quiz 7

quiz -

Stability (ICH) Quiz 7

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 primary purpose of a primary batch in stability studies?

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Question 2: What distinguishes a production batch from other batches in manufacturing?

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Question 3: What is the purpose of a re-test date for a drug substance?

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Question 4: What defines semi-permeable containers in pharmaceutical packaging?

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Question 5: What is the main consideration when determining the shelf life of a drug product?

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Question 6: What does the term "Specification - Release" refer to in the context of pharmaceuticals?

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Question 7: What does the "Specification - Shelf life" encompass in pharmaceuticals?

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Question 8 : What are storage condition tolerances in formal stability studies?

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Question 10: What is the main goal of stress testing for a drug product?

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Question 9: What is the purpose of stress testing for a drug substance?

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