Quality Assurance Interview Questions In Pharma Industry

Post By: Bhagyashree Prashant Devmore

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Common Pharmaceutical Interview Questions For All

1. Introduce yourself

• Your introduction should include

• Your name

• Your education qualifications

• College/university

• Pass out year

• From where you came

• Your experience if any

• What you did in the previous company in short like your designation

• Your family background in short

QA Interview Questions In Pharma

2. What do you know about our company?

• While answering this question you should give the whole summary in short. Name of company

• Established with year   

• Regulatory certification or approvals

• Name of some products

• Board of directors some main designations

• Some points of improvement of a company like awards and certification

• Revenue

3. Why would you like to join our company?

• While answering this question one should include improvement of the company, new work style with software, to learn that, for personal improvement, or growth and any justified personal reason.

4. Why you are leaving your previous company?

• Be a prepared experience person. Every time you have to answer this question.

• Cross-questioning will happen for this regarding your stability in one company.

• This time you can tell that you are changing your company for your personal growth and for your own development Or for your personal reasons

5. Your strength and weaknesses

• Each person has some weaknesses and strengths. You should give examples of your strength and weaknesses. For eg. I am a master in computer systems hardware and software i.e. will be the strength, however, each I am helping others i.e. my weakness.

Speak in a way that should be justifiable and will be in the company's profit. 

6. Your achievement:

• Mention your achievements in your academics, your success stories of your current working company. Your leadership quality and have you been ever worked in a group.

8. Tell me about your goal:

• You should tell your short-term and long-term goals. For example, joining a reputed organization will be your short-term goal; however, achieving a higher position in mentioned reputed organization will be your long-term goal. This may vary from person to person as each person has different goal settings and role models.

9. Tell me about your experience in an internship in the pharma:

Tell the internship program details in pharma.

10. Do you want to ask something?

• This is time to ask them don't let it go ask about the company timing training period, bus facilities, canteen facilities, accommodation, section allocated to work and joining date.

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QA Interview Questions:

1. What is Quality Assurance?

• Quality assurance is a department in the pharmaceutical industry that ensures the quality of products manufactured in the company. In general quality assurance ensures that all medicine manufactured in the company and reaches to patients are safe and effective.

• QA is a broad concept that covers all matters that influence the identity, strength, quality, and purity of drug products.

2. Difference between QA and QC

• QC is a subset of QA that deals with testing materials and drug products to determine if they meet acceptance criteria. The QA function typically consists of oversight activities and the QC function consists of execution activities.

3. What are the different types of dosage forms?

• As per route of administration
• Oral
• Parenteral
• Topical
• Nasal
• Ophthalmic
• Veginal
• Rectal
• Otic
• As per physical form
• Solid
• Semisolid
• Liquid
• Gaseous
• Aerosol
• Sterile
• Novel drug delivery system

4. What is a tablet?

• Tablet is a unit solid oral dosage form.

5. What are Evaluation tests of tablets?

• General appearance- organoleptic, size and shape
• Dimensions- length, width, height
• Friability
• Hardness
• Disintegration
• Dissolution
• Uniformity of content
• Assay
• Weight variation

6. What are the Limits of all evaluation tests?

• Hardness 5 to 8 kg
• Friability 0.5 to 1 % of the actual weight of the tablet is acceptable
• Weight variation
• The average weight of 130 or less is 10%
• For average weight 130 to 324 is 7.5 %
• For average weight, more than 324 is 5% difference is allowed.
• Content uniformity
• 9 tablets from the first 10 is must contain not less than 85 % and not more than 115 % of the labeled drug content and the 10th tablet must not contain less than 75% and more than 125% of the label claim.
• If fails all remaining 20 tablets must be assay individually and none may fall 85 to 115% range
• Disintegration test
• For uncoated tablets- 5 to 30 minutes
• For coated tablet - 1 to 2 hr
• Dissolution test
• Stage 1 Six tablets are tested and are acceptable if all of the tablets are not less than the monograph tolerance limit (Q) plus 5% if fail,
• Stage 2: Another six tablets are tested. Take 6 tablets, test individually, Avg. weight 12 tablets are greater or equal to but no one less than (Q-15) %
• If the average of the twelve is greater than or equal to Q and no unit is less than (Q-15) % if fail
• Stage 3: Another 12 tablets are tested. The tablets are acceptable if the average of all 24 tablets is greater than or equal to Q and if no more than 2 tablets are less than (Q-15) %

7. What is the dissolution test?

• A dissolution experiment evaluates the rate and extent that which a compound forms a solution under controlled conditions

8. What is a disintegration test?

• Disintegration testing measures the ability of a tablet to break down into smaller particles or granules to allow the active drug to be absorbed into the body. If you're interested in our disintegration testing, speak with our team of specialists today.

9. What is a friability test?

• Property of the tablet to be in the same state, having some force to withstand the force of handling while packing and shipping is friability of tablet. 
• The Friability of the tablet is measure by using a friability tester in the laboratory or in-process checks. Friability tester is small equipment having transparent plastic rotating wheel type chamber. 
• In which tablets fall down from 6 inches for 100 revolutions of friability tester. RPM for revolution is 25 RPM.
• The first step is to weigh 10 tablets. Then put it in the chamber and start rotations. Tablets will fall from 6 inches for every rotation. 
• After 25 rotations tester will stop. Again reweigh the tablets. Loss of tablets should not be more than 0.5 to 1%.

10. Limits of friability test

• Loss of tablets should not be more than 0.5 to 1%.

11. What is the hardness test for tablets and its limit and unit of measurement of hardness?

• Tablet has some strength to withstand for handling while packing and shipping that strength is called the hardness of the tablet.
• Hardness is measured by the hardness tester.
• The limit for the hardness of tablet is 5 to 8 kg
• Name some hardness tester:
• Monsanto tester
• Pfizer tester
• Erweka tester
• Strong cob tester
• Schleuniger tester

12. What is granulation

• Granulation is the process of forming grains or granules from powder material or solid material. These granules are used to form tablets from granules by compression or these granules are used to filled in capsules or used in the effervescent formulation.

13. Types of granulation

• Wet granulation
• Dry granulation

14. What is FTIR and the range of frequency?

• Type of spectroscopic analysis. It is an instrumental method used to measure the absorption of electromagnetic radiation over the wavelength range between 4000 and 400 cm^-1

15. What are UV and range?

• UV visible spectra are derived when the interaction between incident radiation and the electron cloud in a chromophore results in an electronic transition involving the promotion of one or more outer shells or the bonding electrons from the ground state into higher energy.
• 185 to 380 and 380 to 780 nm

16. What is a limit test?

• Limit tests are analytical tests that are used to identify quantitative or semi-quantitative tests designed to identify small quantities of impurity which is likely to be present in a substance.

17. Types of limit tests

• limit test to identify inorganic impurities
• Chloride
• Sulphate
• Iron
• Lead
• Heavy metal
• Arsenic

18. What is chromatography? 

• Laboratory technique for the separation of components in the mixture. Based on the distribution of components between 2 phases

19. Types of chromatography

• Absorption
• Thin layer
• Column
• Partition

20. What is gas chromatography?

• Gas chromatography (GC) is an analytical technique used to separate the chemical components of a sample mixture and then detect them to determine their presence or absence and/or how much is present.

21. What are in-process checks?

• In-Process Control refers to the checks performed during an activity (it can be manufacturing or packing) in order to monitor and if necessary to adjust the process and/or to ensure that the intermediate or finished product conforms to its specification.

22. What is schedule "M"?

• Schedule M is titled “Good Manufacturing Practices And Requirements Of Premises, Plant And Equipment For Pharmaceutical Products”.  It specify GMP requirements for premises such as buildings, air conditioning, waste management, sanitation of workers, record keeping, etc for pharmaceutical products.

23. What are the different sections in QA?

• IPQA
• Lab QA /analytical QA
• QMS
• Validation
• Environmental monitoring QA

24. How many tables are used in the friability test?

• 20 tablets

25. From how much height tablet falls in the friability test?

• 6 inches

26. Which type of tablet is exempted from the disintegration test?

• Sustained-release tablet

27. What are the Defects of tablets?

• Chipping
• Capping
• Mottling
• Cracking
• Sticking
• Binding
• Laminating
• Double impression
• Blooming
• Infilling
• Bridging

28. Which Machines are used in the tablet manufacturing process?

• Sifter
• Mixer
• FBD
• Granulator
• Compression machine
• Coating pan
• Packing machine

29. What are the parts of the compression machine?

• Tablet Compression Machine Hopper
• Feeder System
• Tablet Press Punches
• Tablet Press Die System
• Tablet Press Turret
• Tablet Press Machine Cam Tracks
• Tablet Press Filling Station & Weight Control
• Compression Rollers
• Tablet Press Ejection Cam
• Take–off blade and Discharge Chute
• Other Tablet Compression Machine Parts

30. What is calibration?

• Calibration is the documented comparison of the measurement device to be calibrated against a traceable reference device.

31. What is validation?

• Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results

32. Types of validation?

• Prospective 
• Retrospective
• Prospective

33. What are bracketing and matrixing?

• Bracketing and matrixing can be done in full study designs that aim to test the new drug substances for every combination of all design factors included in the technical guidelines, or in reduced study designs that focus on testing some of the drug samples or components while ignoring others.