Visual inspection of injectable in pharmaceutical industry l Interview Question and answers

Visual inspection of injectable in pharmaceutical industry l Interview Question and answers
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Questions covered:
Q. What are the regulatory requirements for visual inspection of injectable products?
Q. Why visual inspection of injectable shall be done?
Q. What are the inspection methods for injectable in the pharmaceutical industry as per FDA’s guidance for industry?
Q. What are the limitations of manual visual inspection method?
Q. How the defect categorization is done in visual inspection of injectable?
Q. What is particulate as per FDA’s guidance for industry?
Q. What is pharmacopeia requirement for visual inspection parameter as per USP and EP?
Q. What is human eye capability to identify particle in a injectable container?
Q. Which guideline is referred for AQL sampling plan?
Q. Why presence of particles should be avoided in injectable?
Q. What should be done in reject is observed during visual inspection?
Q. Why break during visual inception shall be given for visual inspectors?
Q. What are the different types of particulates as per FDA’s guidance for industry?
Q. What is difference between intrinsic particles and extrinsic particles in injectable?
Q. Why white and black background used for visual inspection of injectable?
Q. How should visual inspection personnel be trained according to regulatory guidelines?
Q. What guidance is provided in FDA’s guidance for industry about Defect library?
Q. How container integrity checked during visual inspection of injectable?
Q. How are inspectors qualified for visual inspection?
Q. What is the expected inspection rate for manual visual inspection?
Q. What are the major types of injectable rejects?
Q. What is POD i.e. probability of detection of particles with human eye?
Q. What is AQL for visual inspection and what is acceptance criteria, which guideline referred for AQL table?
Q. What is KNAPP kit used in visual inspection of injectable?
Q. Why gentle shaking of glass vial is done during visual inspection?
Q. What are the major sources of black particles in injectable?
Q. Which guidelines are commonly referred for visual inspection of injectable?
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