Tuesday , September 26 2023

Stability (ICH Q1A) Quiz 4

Pharmaguidanaces Channel August 11, 2023 QA & QC, Quality Assurance, Quiz Comments Off on Stability (ICH Q1A) Quiz 4 103 Views

Stability (ICH) Quiz 4

QA -

Stability (ICH) Quiz 4

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 purpose of conducting stability testing on a drug product after constitution or dilution?

2 / 10

Question 2: What does "significant change" for a drug product typically involve?

3 / 10

Question 3: When should a commitment be made to continue stability studies post approval?

4 / 10

Question 4: Under what circumstance is a post approval commitment considered unnecessary?

5 / 10

Question 5: If the submission includes stability data on fewer than three production batches, what additional commitment is required?

6 / 10

Question 6: What happens if significant change occurs at the accelerated storage condition on commitment batches?

7 / 10

Question 7: What should be consistent between the stability protocol for commitment batches and the primary batches?

8 / 10

Question 8: What should be consistent between the stability protocol for commitment batches and the primary batches?

9 / 10

Question 9: Under what conditions can testing on commitment batches be conducted at the intermediate storage condition?

10 / 10

Question 10: What attributes of the dosage form might be considered in stability testing?

Your score is

The average score is 41%

0%

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 …

Powered by WordPress | Designed by TieLabs
© Copyright 2023, All Rights Reserved
error: Content is protected !!