Top Pharma Quality Assurance Interviews Questions & Answers

Top Pharma Quality Assurance Interviews Questions & Answers

Question 1. What Is An Sop ?

Answer : Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step likewise

Question 2. What Is cGMP ?

Answer : cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities also include.

Question 3. What Is An Iq Document ?

Answer : Installation Qualifications are a collection of test cases use to verify the proper installation of a System. The requirement to properly install the system was define in the Design Specification also. Installation Qualifications must be performe before completing Operational Qualification and Performance Qualification.

Question 4. What Is An Oq Document ?

Answer : Operational Qualifications are a collection of test cases use to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements also. Operational Qualifications are usually perform before the system is released for use.

Question 5. What Is A Pq Document ?

Answer : Performance Qualifications are a collection of test cases use to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were define in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conduct with power users as the system is being released.

Question 6. Difference Between GMP & cGMP ?

Answer : Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produce and controlld according to quality standards. It is design to minimize the risks involve in any pharmaceutical production that cannot be eliminated through testing the final product also.

cGMP in full is the Current Good Manufacturing Practice. These guidelines ensure the right designs, monitoring procedures and the required control of the manufacturing processes and the facilities used also.

Question 7. Countries Comes Under Climatic Zone Ivb?

Answer :  Brazil, Cuba, China, Brunei, Cambodia, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand

Question 8. What Is The Purpose Of Stress Testing In Stability Studies?

Answer : Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used likewise. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved also.

Question 9. What Is Dead Leg?

Answer : A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.

Question 10. How Many Tablets Shall Be Taken For Checking Friability?

Answer : For tablets with unit mass equal or less than 650 mg, take  sample of whole tablets corresponding to 6.

Question 11. What Is The Standard Number Of Rotations Used For Friability Test?

Answer : 100 rotations

Question 12. Which Capsule Is Bigger In Size – Size ‘0’ Or Size ‘1’?

Answer : ‘0’ size

Question 13. Which Method Is Employed For Checking “uniformity Of Dosage Unit”?

Answer : Content uniformity

Question 14. What Is The Difference Between Calibration And Validation?

Answer :Calibration is a demonstration that, a particular

Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements also.

Where as Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria also.

In calibration performance of an instrument or device is comparing against a reference standard likewise. But in validation such reference standard is not using.

Calibration ensures that instrument or measuring devices producing accurate results certainly. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).

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