Cleaning Validation in Pharmaceutical industry l Interview Questions
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Questions covered
Q.1 : What is cleaning validation ?
Q.2 : When we should perform cleaning validation ?
Q.3 : Which guidelines are referred for cleaning validation ?
Q.4 : What are MACO, NOEL and PDE terms used in cleaning validation?
Q.5 : What is formula for MACO calculation ?
Q.6 : Why three cleaning cycles are considered during cleaning validation run?
Q.7 : What is dirty hold time?
Q.8 : What is clean hold time?
Q.9 : Which hold times shall be validated during cleaning validation?
Q.10 : What are the commonly used sampling techniques during cleaning validation?
Q.11 : What you should do first rinse or swab if you are doing both ?
Q.12 : What are the advantages and limitations of rinse sampling ?
Q.13 : What are the basic requirement's for rinse sampling ?
Q.14 : What are the advantages and limitations of swab sampling ?
Q.15 : Which key parameters shall be considered for preparation of risk assessment for cleaning validation?
Q.16 : What is Equipment grouping and Product grouping?
Q.17 :What are the CIP systems ?
Q.18 : Which study shall be performed for cleaning agents during cleaning validation ?
Q.19 : Why TOC testing is done during cleaning validation ?
Q.20 : What are the non specific analytical tests for cleaning verification?
Q.21 : How we can enhance training practices of cleaning procedure ?
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