Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 1)

1. What is 21 CFR part  ?

Title 21 CFR Part of the Code of Federal Regulations deals with the Food and Drug Administration (FDA)

2. Different between Qualification and Validation?

“Qualification” refers to the activities performed on facility, utility and equipment
The “Validation” refers to the activities performed on processes, practices and methods.

Air Changes Calculations in clean rooms

Step 1: Measure the length, width and height of the room using a good old fashioned tape measure :-) This will determine the size of the room or in other words its volume.

Length x Width x Height =

Step 2: Using a device called a ‘balometer’ measure the air supply coming out of the HEPA terminal. You do this by holding the balometer up to the HEPA terminal. The balometer will catch the downstream of air flowing into the cleanrooms and measures the cascade speed.

 Step 3: Once you have your cascade speed your next step is to multiply this figure by 3,600 and divide by the room volume.

 3,600 = Number of seconds per hour

Remember to round up to 1 decimal point on your final answer!