pharma interview questions and answers for fresher
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| pharma interview questions and answers |
Question 151- Explain About Revalidation Criteria Of Ahu System?
AHU shall be revalidated in the following cases also:
- When the basic design of AHU is changed,
- When cleanroom volume is changed,
- When new equipment is installed
- When construction is carried out, that calls for the reconstruction of the AHU system.
Question 152- What Needs To Be Checked During Ahu
Validation?
Answer :
During AHU validation, the following tests shall be
carried out:
- Filter efficiency test,
- Air velocity & number of air changes,
- Airflow pattern (visualization)
- Differential pressure, temperature, and RH
- Static condition area qualification
- Dynamic condition qualification
- Non-viable count
- Microbial monitoring
- Area recovery and power failure study.
Question 153 Position Of Oblong Tablets To Be Placed In
Hardness Tester To Determine The Hardness? Lengthwise / Widthwise?
Answer :
- Position of oblong tablets should be lengthwise because the probability of breakage is more in this position.
Question 154- Explain In Detail About Qualification Of
Pharmaceutical Water System?
Answer :
Qualification of pharmaceutical water system involves
three phases:
- Phase -1
- Phase -2
- Phase -3
- Phase -1:
A test period of 2-4 weeks should be spent on
monitoring the system intensively. During this period the system should operate
continuously without failure or performance deviation. Water cannot be used for
pharmaceutical manufacturing in this phase. The following should be included in
the testing approach.
- Undertake chemical & microbiological testing by a defined plan.
- Sample incoming feed water daily to verify its quality.
- Sample each step of the purification process daily.
- Sample each point of use daily.
- Develop appropriate operating ranges.
- Demonstrate the production and delivery of the product the water of the required quantity and quality.
- Use and refine the SOPs for operation, maintenance, sanitization, and troubleshooting.
- Verify provisional alert and action levels.
- Develop and refine test failure procedure.
Phase -2:
A further test period of 2-4 weeks. Sampling scheme
will be the same as Phase 1.Water can be used for the manufacturing process in
this phase. Approach should also
- Demonstrate consistent operation within established ranges.
- Demonstrate consistent production & delivery of water of required quality and quantity.
Phase - 3:
Phase 3 runs for one year after satisfactory completion
of phase-2. Water can be used for manufacturing process during this process.
Objectives & Features of Phase -3:
- Demonstrate extensive reliable performance.
- Ensure that seasonal variations are evaluated.
- The sample locations, sampling frequencies, and the test should be reduced to the normal routine pattern based on established procedures proven during Phase -1 & phase - 2.
Question 155- What Is The Difference Between
Calibration And Validation?
Answer :
Calibration is a demonstration that, a particular
- Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
- Whereas Validation is a documented program that provides a high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
- In calibration performance of an instrument or device is comparing against a reference standard. But invalidation, such reference standard is not using.
- Calibration ensures that instrument or measuring devices producing accurate results. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).
Question 156- Briefly Explain About Ich Climatic Zones
For Stability Testing & Long Term Storage Conditions?
Answer :
ICH STABILITY ZONES:
Zone: Type of Climate
Zone I: Temperate zone
Zone II: Mediterranean/subtropical zone
Zone III: Hot dry zone
Zone IVa: Hot humid/tropical zone
Zone IVb:
ASEAN testing conditions hot/higher humidity
Long term Storage condition
Climatic Zone
Temperature
Humidity
Minimum Duration:
Zone I:
21C 2C
45% rH 5% rH
12 Months
Zone II:
25C 2C
60% rH 5% rH
12 Months
Zone III:
30C 2C
35% rH 5% rH
12 Months
Zone IV:
30C 2C
65% rH 5% rH
12 Months
Zone IVb:
30C 2C
75% rH 5% rH
12 Months
Refrigerated
5C 3C
No Humidity
12 Months
Frozen
-15C 5C
No Humidity
12 Months
Question 157- What Are The Common Variables In The
Manufacturing Of Tablets?
Answer :
The particle size of the drug substance:
- Bulk density of drug substance/excipients
- Powder load in the granulator
- Amount & concentration of binder
- Mixer speed & mixing timings
- Granulation moisture content
- Milling conditions
- Lubricant blending times
- Tablet hardness
- Coating solution spray rate
Question158- Whether Bracketing & Validation
Concept Can Be Applied In Process Validation?
Answer :
Both Matrixing and Bracketing can be applied in
validation studies.
- Matrixing
- Different strength of the same product
- Different size of the same equipment
- Bracketing - Evaluating extremes
- Largest and smallest fill volumes
- Fastest and slowest operating speeds
Q159-What are the pros and cons of working at a small
pharmaceutical company versus one of the biggies?
There are a lot of advantages to working for a small
pharmaceutical company. First of all, a small company may be more willing to
take a chance on somebody with less experience.
It is easier for you to shine and advance at small pharmaceutical
companies. Also, small pharmaceutical companies can become big pharmaceutical
companies very rapidly. Small companies offer stock options as an incentive to
stay with them long-term. Often, small companies get acquired by larger
companies, and the original stockholders get wealthy.
However, working for a small pharmaceutical company is
riskier than working for a big one. If your company has a small stable of
products, that means you have all your eggs in one basket.
Small pharmaceutical companies don't provide big
expense accounts for entertaining clients, and you don't have as much marketing
support. Also, the territories are bigger so you have to drive more. Instead of
working a territory that's 3 hours end-to-end, your territory may be an entire
state.
Q160-What is the difference between quality assurance
and quality control?
Quality control is the process of identifying the
defect and quality assurance is a process of improvement Quality control is
reactive Action quality assurance is a protective action QC is a set of
actions. Quality control takes CORRECTIVE ACTION during production,
Quality Assurance takes PREVENTIVE ACTION during
development or after production (for completely prevention, if any defect
arises)
What is the difference between Quality Assurance,
Quality Control, and Audit Function?
Quality assurance is a set of activities involved in
the processes and Quality control is a set of activities involved in product
and audit function is nothing but the periodic inspection in the quality
system.
Q161-What does 6 Sigma represent?
Six Sigma represents the six standard deviations from
the mean toward the upper specification limit in a normally distributed sample
where an average of 3.4 defects per million is reported to live.
Differentiate between product quality and process
quality.
Product quality deals with the given specification of
an individual product whereas the process quality deals with the process the capability of the process that how much it can be effective to produce the
quality products.
Q162-What is the maximum Acceptable Tolerance Limit for
any product?
It is a TOLERANCE limit which is set by CONSUMER for
acceptable any lot, parts, etc, generally within +/-5%
Q163-How do you track bug and report through Quality
Control dept?
Tracking by sampling process, through
FIR (Final Inspection Report)
FOI (First off Approval Inspection Report)
Patrol Inspection Report
In Quality Assurance Plan & QC, what can be
implemented to reduce rework in Acoustic Enclosure for a manufacturing company?
Proper machine maintenance,
Consistent quality checks on the product,
Purchasing of quality raw materials,
Training and awareness of the operating procedure of
the machine.
Quality Control Executive Interview Questions &
Answers QA + QC PDF Pharma Company Job Interview
Q164-When do we use a c-chart?
- C chart is used when the item is too complex to analyze the product for confirming or not- confirming and subgroup size is the same. It is used to monitor the number of defects per unit
Q165-What is meant by risk? How can you avoid the
risks?
A risk is a possibility that an unfavorable event may
occur. It may be predictable or unpredictable. A risk may have 3 components:
- The event that could occur;
- The probability that the event will occur;
- The impact/consequences of the event that if it occurs.
One can avoid Risk by
Identifying the Risk, 2. Quantifying the risk i.e. by
Risk identification & Risk Prioritization. 3. Risk Response Development
4.Risk Resolution & Risk Monitoring.
Q166.Answers all the question (Each correct answer
carry one mark)
1. Identify the falling height during the Tablet
Friability testing?
a. 6 inches
b. 5 inches
c. 8 inches
d. 4 inches
2. Capsule sizes are given below. Which one is the
bigger size form below given options?
a. 00
b. 0
c. 3
d. 000
3. Acceptable mean weight loss for the three tablets
during the Friability testing is
a. 1%
b. 5%
c. 3%
d. 2%
4. Unequal distribution of a tablet color is known as
a. Double impression b. Filming c.Mottling d.Capping
5. Which of the following quality control test is not
conducted for parenteral?
a. Content uniformity test b. Leaker test c.Clarity
test d.Dissolution test
6. Which of the following are used to test the tablet
hardness?
a. Monsanto hardness tester
b. Strong cob tester
c. Pfizer tester
d. All of the above
7. What is measuring unit of tablet hardness?
a. Kg/cm2
b. Kg/cm3
c. %
d. Kg
8. Which of the following drug is an alpha +
beta-blocker?
a. Sotalol
b. Atenolol
c. Labetalol
d. Metoprolol
9. How much percentage of moisture present in an empty
capsule?
a. 33%
b. 10-15%
c. 50-70%
d. 80%
10. Pyrogen test is conducted for parenteral
formulations. What is the minimum volume used for this test?
a. 5ml
b. 10ml
c.15 ml
d. 20 ml
11. Which of the following drug is used to treat
malaria?
a.Terbinafine
b.Mefloquine
c. Nystatin
d. Famciclovir
12. Which of the following class of drugs are not used
to treat diabetes mellitus?
a. Sulfonylureas
b. GLP 1 agonists
c. DPP 4 inhibitors
d.Carbonic anhydrase inhibitors
13. Capsule sizes are given below. Which one is the
smaller size form below given options?
a) 00
b) 0
c) 3
d) 000
14. What UltraViolet(UV) range?
a. 380 -750nm
b. 400 700nm
c. 190 380 nm
d. None of the above
15. Which of the following dye solution is used for
performing the leaker test?
a.1% methylene blue
b. 5% methylene blue
c.10% methylene blue
d. 20% methylene blue
16. Aerosols storage condition is
a. Below 120 0F
b. Below 160 0F
c. Below 105 0F
d. Below 95 0F
17. Which of the following drug is a potassium-sparing
diuretic?
a. Furosemide
b. Indapamide
c.Acetazolamide
d. Amiloride
18. Pick out the standard number of rotations used for
friability test?
a. 50
b. 200
c. 500
d. 100
19. What is the pH of blood?
a. 25 7.35
b. 35 7.45
c. 15 7.25
d. 45 7.55
20. Acetylsalicylic acid is known as
a. Paracetamol
b. Aspirin
c. Ibuprofen
d. Ketamine
Answers:
1.a2.d 3.a 4.c 5.d 6.d 7.a 8.c 9.c 10.C 11.b 12.d 13.c
14.a 15.a 16.a 17.d 18.d 19.b 20.b
Pharma Interview Questions and Answers:PART-3
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