Lupin Executive Regulatory Affairs Interview Questions and Answers

Filling machine can be qualified by performing various tests and inspections.

• Performing visual inspection of the machine

• Checking the accuracy of the filling volume

• Testing the machine's speed and efficiency

• Verifying the machine's compatibility with the product being filled

• Ensuring the machine meets regulatory requirements

• Conducting validation tests to ensure consistent performance

Media fill frequency depends on the risk level of the product and process.

• Media fill should be performed at least once per shift for high-risk products and processes.

• For low-risk products and processes, media fill can be performed less frequently.

• The frequency of media fill should be determined by the validation team based on risk assessment.

• Media fill should also be performed after any significant process changes or e...read more

Media fill duration is the time taken to complete a simulation of aseptic manufacturing process.

• Media fill is a simulation of the aseptic manufacturing process.

• It involves filling sterile media into containers under aseptic conditions.

• The duration of media fill depends on the product being manufactured and the process being simulated.

• Typically, media fill can take anywhere from a few hours to a few days.

• The duration of...read more

Smoke study is a process of introducing smoke into a controlled environment to observe the flow of air or gas.

• It is used to identify leaks or blockages in ventilation systems.

• It can also be used to test the effectiveness of air filtration systems.

• Smoke study is commonly used in industries such as pharmaceuticals, food processing, and HVAC.

• The smoke used in the study is usually non-toxic and harmless to humans and anima