ICH Q3A l Impurities in New Drug substance l Organic impurities in pharmaceutical industry Interview Question and answers
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Questions covered:
Q. What is ICH Q3A Guideline and why it is important ?
Q. What is classification of impurities as per ICH Q3 A?
Q. What is an impurity as per ICH Q3A ?
Q. What is an impurity profile as per ICH Q3A ?
Q. What are organic impurities as per ICH Q3A?
Q. What are inorganic impurities as per ICH Q3A?
Q. What are the requirements for analytical procedures in impurity detection and quantification in registration applications ?
Q. What is potential impurity as per ICH Q3A?
Q. What is enantiomeric impurity as per ICH Q3A?
Q. What are residual solvent impurities as per ICH Q3A ?
Q. What is identified impurity as per ICH Q3A ?
Q. What is unidentified impurity as per ICH Q3A ?
Q. What is impurity qualification as per ICH Q3A ?
Q. What are the different types of thresholds mentioned in the guideline ?
Q. What are Identification Threshold, Qualification Threshold and Reporting Threshold ?
Q. What is decision tree for impurities identification and qualification ?
Q. How should differences between development and commercial analytical procedures for impurity analysis be addressed in a registration application ?
Q. What are the validation requirements for analytical procedures in impurity detection and quantification according to ICH Q3A ?
Q: Which type of products are not covered in the ICH Q3 A ?
Q. What impurity details should new drug substance should include as per ICH Q3A ?
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