736 _ Industrial Pharmacy: A Comprehensive Approach Model Questions Questions carrying 1-2 marks 1. What is Q guideline? 2. What is E guideline? 3. What is S guideline? 4. What is M guideline? 5. Name the analytical procedures/tests need to be validated? Name the variations commonly take place in chromatographic analysis? 7. According to validation guidelines under what circumstances revalidation becomes necessary? 8. Classify impurities with respect to new drug substance as per ICH guideline for validation of analytical procedure? 9. Which information are to be documented in the registration application for each batch of new drug product? 10. What is product life-cycle? Questions carrying 3-5 marks 1, What is meant by climatic zone? On which basis climatic zone has been classified? ‘Which observations during stability study are considered to be significant change? ‘What is the testing frequency for short term and long term stability study? How the photostability testing is carried out as per ICH guideline for stability study? Explain the term ‘source of light’? yeen 6. How the decision on results of stability study is taken? 7. Explain the term ‘impurities’ as per ICH guideline for validation of analytical procedure? & How the residual solvents in pharmaceutical guideline for the safety of the patient? 9. Explain three major objectives of ICH Q10 guideline which facilitate smooth implementation of regional GMP requirements as well as regulatory requirements? 10. Write note on knowledge management and risk management? have been classified in the ICH Questions carrying 5-6 marks 1. Discuss the tests to be conducted on new drug substances and new dosage form as per ICH guideline for stability testing? Ul O <