ICH Q7 Guideline l Active pharmaceutical ingredient in pharmaceutical industry l API in pharma l

ICH Q7 Guideline l Active pharmaceutical ingredient in pharmaceutical industry l API in pharmaceutical industry l Interview Question and answers
Link to download Guideline : database.ich.o...
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Questions covered:
Q. What is ICH Q7 Guideline and why it is important ?
Q. What is Oct 2022 update for ICH Q7 ?
Q. What are the various sections of ICH Q 7 Guideline ?
Q. What is API or drug substance as per ICH Q7 ?
Q. What is scope application of ICH Q7 guideline?
Q. What are personnel hygiene requirement as per ICH Q7 ?
Q. What is personnel qualification requirement as per ICH Q7 ?
Q.: What are critical process parameters according to ICH Q7?
Q. How should deviations be handled according to ICH Q7 ?
Q. What are the design and construction requirements for API manufacturing facility as per ICH Q7 ?
Q. What are the utilities requirements as per ICH Q7 ?
Q. What are the Water requirements as per ICH Q7 ?
Q. What are the other requirements as per ICH Q7 ?
Q. What are the responsibilities of Quality Unit per ICH Q7 ?
Q. What are the responsibilities of Production Unit per ICH Q7 ?
Q. What is expectation from self inspections per ICH Q7 ?
Q. What is expectation from product quality review as per ICH Q7 ?
Q. What are equipment cleaning and maintenance requirements as per ICH Q7 ?
Q. What are the calibration requirements as per ICH Q7 ?
Q. What controls about material management are mentioned in ICH Q7 ?
Q. What controls about production and in-process controls mentioned in ICH Q7 ?
Q. What are the controls about packaging and identification labelling of API and intermediates as per ICH Q7 ?
Q. What are controls about Storage and distribution of API’s per ICH Q7 ?
Q. What are Laboratory controls of API’s per ICH Q7 ?
Q. What are key controls about Validation of procedures for API’s per ICH Q7 ?
Q. How does ICH Q7 guides about API reprocessing procedure ?
Q. How does ICH Q7 guides about recovery procedure ?
Q. What are the important guidelines for API manufacturing ?
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[@PharmGrow]

Link to download ICH Q7 Guideline : database.ich.org/sites/default/files/Q7%20Guideline.pdf

[@muralikrishnapatchineela3508]

Good information 👍

[@PharmGrow]

Thank you 👍