ICH Guidelines (International Council for Harmonization) in pharmaceutical industry. Q & A.

ICH Guidelines (International Council for Harmonization) in pharmaceutical industry. 20 Interview Question and answers.
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1. QMS - Quality Management System in Pharmaceutical industry :    • QMS - Quality Management System in Ph...  
2. QA- Quality assurance in Pharmaceutical industry. :    • QA- Quality assurance in Pharmaceutic...  
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Questions covered:
Q: What is the primary objective of ICH guidelines in the pharmaceutical industry?
Q. What is correct full form of ICH ?
Q: How are ICH guidelines developed and updated ?
Q: What are the main regions involved in ICH collaboration?
Q: What is the significance of ICH Q1A and Q1B guidelines in stability testing?
Q: As per ICH guideline, how many key principles are for Good Clinical Practice (GCP) ?
Q: What is the purpose of ICH Q2 guidelines regarding analytical method validation?
Q: Explain the key concepts in ICH Q3 guidelines related to impurities in pharmaceuticals?
Q. What are the key steps risk assessment according to ICH Q9 ?
Q. : How can ICH guidelines be applied to the management of post-approval changes in pharmaceutical products, as outlined in ICH Q12?
Q. : What are the major categories of ICH guidelines, and what do they cover?
Q. : What are the different climatic zones as per ICH Guideline ?
Q: How do ICH Q12 guidelines promote the lifecycle management of pharmaceutical products?
Q. : What is the role of ICH E6 guidelines in the conduct of clinical trials for pharmaceutical products?
Q.What are the key differences between ICH guidelines and national regulatory requirements?
Q. : Which tragedy lead to formation of ICH guidelines?
Q. : What is the significance of the QbD (Quality by Design) concept in ICH guidelines?
Q. : What is the role of ICH guidelines in ensuring the quality and integrity of pharmaceutical data and documentation ?
Q. List down all ICH guidelines in Q-Series?
Q. Which countries are part of ICH and plays key role in ICH ?
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