Tuesday , September 26 2023

Stability (ICH Q1A) Quiz 7

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.

1 / 10

Question 1: What is the primary purpose of a primary batch in stability studies?

2 / 10

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

3 / 10

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

4 / 10

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

5 / 10

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

6 / 10

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

7 / 10

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

8 / 10

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

9 / 10

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

10 / 10

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

Your score is

The average score is 55%


About Pharmaguidanaces Channel

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

Internal Audit and Self Inspection

Internal Audit and Self Inspection Internal Audit: An onsite verification of activity used to determine …

error: Content is protected !!