Pharma Treasures - Quality Assurance (Pharma) Frequently Asked Interview Questions

3/18/2018 Pharma Treasures: Quality Assurance (pharma) frequently asked interview questions
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Wednesday, 25 January 2012 About Me

Don
Quality Assurance (pharma) frequently asked interview questions
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Sr. Questions & Answers
No.
1. Q. Why water for pharmaceutical use is
always kept in close loop in continuous
circulation ?
A. Water is a best medium for many
microorganisms, microorganism can be a
highly pathogenic which causes serious
diseases(many diseases are water born),
these pathogens infect after consumption of
contaminated water, microorganisms tend to
settle on a surface if water is allowed to stand
in a stagnant position for few hours, these
settled microorganism form a film over the
surface of vessel and piping, such film formed
by microorganisms is also called as biofilm,
biofilms are very difficult of remove, once a
biofilm is formed at a particular point then that
point may form a biofilm again even after
cleaning very easily as seed from this point is
may not completely get removed effectively.

Biofilms then can become a source of microbial
contaminations; therefore purified water after
collection in a distribution system is always
kept in a closed loop in a continuous
circulation.
A continuous circulation is also not enough at
some points, therefore it is aided with high
temperature range from 65 °C to 80°C, a
minimum temperature of 65 °C is considered a
self sanitizing, but better assurance is obtained
with a temperature of 80°C .

Purified water collected should be stored in a
stainless still vessel which must facilitate
distribution to the point of use in a closed loop
of continuous circulation, tank should be made
of corrosion free material of construction, and
must facilitate sanitization and easy cleaning.

2. Q. Water for pharmaceutical use shall be
free cations,anions and other impurities
why ?

A.Water for pharmaceutical must be free from
inorganic as well as organic impurities,
minerals, and heavy metals. Some impurities
like calcium, magnesium, ferrous are
responsible for degradation of drug molecule,
many cations like ferrous and calcium
magnesium act as catalysts in degradation
reaction of drug molecule, anions like chloride
are highly active they participate in nucliophylic
substitution reactions, where in they break a
double bond between C=C in to a single bond
as CL –CHCH2 , which a reason why we
observe that color dies tend to fed in presence
of chlorine as most of the dies used are diazo
compounds which has plenty of places for
nucliophylic substitution reactions, which is
also a reason why stability of drug is drastically
affected in presence of cations and anions from
mineral origin present in water.

3. Q. Water for pharmaceutical use shall be
free heavy metals why ?
A. Heavy metals like lead and arsenic are
highly cumulative neurotoxic metals, heavy
metals are not eliminated out of our body easily
like other drugs and molecules but heavy
metals bind with proteins and tend to get
accumulated in fatty tissues, nerve tissue is
most likely to get damaged by heavy metals,
heavy metal causes nervous tissue damage
there for water must be free from heavy metals.

4. Q. Brazil falls under which climatic zone ?
A. Zone IVB (30 degree celsius and 75%
relative humidity)

5. Q. Change in the size or shape of the
original container requires any stability

study?
A. Change in the size or shape of the original
container may not necessitate the initiation of
new stability study.

6. Q. Forced degradation(stress testing) and
accelerated stability testing are same?
A. Forced degradation and stress testing are
not same. Stress testing is likely to be carried
out on a single batch of the drug substance.
The testing should include the effect of
temperatures (in 10°C increments (e.g., 50°C,
60°C) above that for accelerated testing),
humidity (e.g., 75 percent relative humidity
or greater) where appropriate, oxidation, and
photolysis on the drug substance. The testing
should also evaluate the susceptibility of the
drug substance to hydrolysis across a wide
range of pH values when in solution or
suspension. Photo stability testing should be
an integral part of stress testing.

7. Q. According to WHO guidelines what is the
storage condition of climatic zone IVa and
zone IVb?
A. Zone IV a: 30°C and 65% RH (hot and
humid countries)
Zone IV b: 30°C and 75% RH (hot and very
humid countries

8. Q. Countries comes under climatic zone IVb?
A.
Brazil,Cuba,China,Brunei,Cambodia,Indonesia,
Malaysia,Myanmar,Philippines,Singapore,Thail
and

9. Q. What is the purpose of stress testing in
stability studies?
A. 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. The nature of the stress
testing will depend on the individual drug
substance and the type of drug product
involved.

10. Q. What is the formula for calculating
number of air changes in an area?

A. Number of air changes/hour in an area is

= Total Room Airflow In CFM x 60
Total Volume of room in cubic feet
For calculating Total Room Airflow in CFM, first
calculate air flow of individual filter. Formula is
given below.

Air flow (in cfm) = Avg.air velocity in feet/Minute
x Effective area of filter

Then find Total air flow. Formula is
Total Air flow = Sum of air flow of individual
filter.

Air flow Velocity can be measured with the help
of Anemometer.

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

12. Q. What is the recommended bio burden
limits of purified water & WFI?
A. Purified water has a recommended
bioburden limit of 100 CFU/mL, and water for
injection (WFI) has a recommended bio burden
limit of 10 CFU/100 mL.
13. Q. Brief about ICH stabilty guidelines?
A. Q1A Stability testing of new drug substance
& products
Q1B Photo stability testing of new drug
substances & products
Q1CStability testing of new dosage forms
Q1DBracketing & Matrixing designs for testing
of new drug substances and products
Q1EEvaluation of stability data
Q1FStability data package for registration
applications in climatic zone III & IV
(Withdrawed)

14. Q. What is significant changes in stability
testing?
A.
1. A 5% change in assay for initial value.

2. Any degradation products exceeds its
acceptance
criterion.

3. Failure to meet acceptance criterion for
appearance,physical artributes and
functionality
test.

4. Failure to meet acceptance criteria for
dissolution
for 12 units.

15. Q. If leak test fail during in process checks
what needs to be done ?
A.
Immediately stop packing process and check
for
1.Sealing temperature
2.Verify for any possible changes like foil
width,knurling etc.
3.Check & quarantine the isolated quantity of
packed goods from last passed inprocess.
4.Collect random samples & do retest.
5.Blisters from the leak test passed containers
shall allow to go further and rest must be
deblistered/defoiled accordingly.

16. Q. How many Tablets shall be taken for
checking friability?
A. For tablets with unit mass equal or less than
650 mg, take sample of whole tablets
corresponding to 6.5g.For tablets with unit
mass more than 650mg,take a sample of 10
whole tablets.

17. Q. What is the formula for calculating
weight loss during friability test?
A. %Weight loss = Initial Weight Final Weight X
100
Initial Weight

18. Q. What is the pass or fail criteria for
friability test?
A. Generally the test is run for once.If any
cracked,cleaved or broken tablets present in
the tablet sample after tumbling,the tablets fails
the test.If the results are doubtful,or weight loss
is grater than the targeted value,the test should
be repeated twice and the mean of the three
tests determined.A mean weight loss from the
three samples of not more than 1.0% is
considered acceptable for most of the
products.

19. Q. What is the standard number of rotations
used for friability test?
A. 100 rotations

20. Q. What is the fall height of the tablets in
the friabilator during friability testing?
A. 6 inches.Tablets falls from 6 inches eight in
each turn within the apparatus.

21. Q. Why do we check hardness during
inprocess checks?
A. To determine need for the pressure
adjustments on the tableting machine.
Hardness can affect the disintegration time.If
tablet is too hard, it may not disintegrate in the
required period of time. And if tablet is too soft
it will not withstand handling and subsequent
processing such as coating,packing etc.

22. Q. What are the factors which influence
tablet hardness?
A.
1.compression force
2.Binder quantity(More binder more
hardness)
3.Moisture content

23. Q. Which type of tablets are exempted from
Disintegration testing?
A. Chewable Tablets

24. Q. Which capsule is bigger in size size '0'
or size '1'?
A. '0' size

25. Q. What is the recommended temperature
for checking DT of a dispersible tablet?
A. 25 ±10C (IP) & 15 – 250C (BP)

26. Q. What is mesh aperture of DT apparatus ?
A. 1.8 2.2mm (#10)

27. Q. What is the pass/fail criteria for
disintegration test?

A. If one or two tablets/capsules fails to
disintegrate completely, repeat the test on
another 12 additional dosage units. The
requirement is meet if not fewer than 16 out of
18 tablets/capsules tested are disintegrated
completely.

28. Q. What is the recommended storage
conditions for empty hard gelatin capsules?
A. 15 250C & 35 55% RH

29. Q. Which method is employed for checking
“Uniformity of dosage unit”?
A.
A.)Content uniformity
B.) Weight Variation

Weight variation is applicable for following
dosage forms;Hard gelatin capsules,uncoated
or film coated tablets,containing 25mg or more
of a drug substance comprising 25% or more
by weight of dosage unit.

30. Q. What is the recommended upward and
downward movement frequency of a
basketrack assembly in a DT apparatus?
A. 28 – 32 cycles per minute.

31. Q. When performing the ‘uniformity of
weight’ of the dosage unit, how many
tablet/capsule can deviate the established
limit?
A. Not more than two of the individual weights
can deviates from the average weight by more
than the percentage given in the
pharmacopeia,and none can deviates more
than twice that percentage.
Weight Variation limits for Tablets

IP/BP Limit USP

80 mg or less 10% 130mg or less
More than 80mg 7.5% 130mg to 324mg
or Less than
250mg
250mg or more 5% More than
324mg

Weight Variation limits for Capsules
IP Limit
Less than 300mg 10%
300mg or More 7.5%
32. Q. What needs to be checked during
inprocess QA checks?
A.
a.) Environmental Monitoring
b.) Measured values obtained from the process
equipment (ex:temperature,RPM etc.)
c.) Measured values obtained from persons
(ex:timmings,entries etc.)
d.) Process attributes
(Ex:weight,hardness,friability etc.)

33. Q. What precautions shall be taken while
collecting inprocess samples ?
A. While collecting inprocess samples, avoid
contamination of the product being sampled
(Don’t collect samples with bare hands) &
avoid contamination of sample taken.

34. Q. In a tablet manufacturing facility
‘positive’ pressure is maintained in
processing area or service corridors?
A. In tablet manufacturing facilities, pressure
gradients are maintained to avoid cross
contamination of products through air. Usually
processing areas are maintained under positive
pressure with respect to service corridors.

35. Q. If sticking observed during tablet
compression what may the probable reason
for the same?
A.
1.If the granules are not dried properly sticking
can
occur.
2.Too little or improper lubrication can also
leads to
sticking.
3.Sticking can occur because of too much
binder or
hygroscopic granular.

36. Q. What checks shall be carried out, while
calibrating DT apparatus?
A. While calibrating DT apparatus, following
checks shall be performed.
1.) Number of strokes per minute (Limit:29

32 cycles/min)
2.) Temperature by probe & standard

thermometer
(Limit: 37 ± 1 OC).
3). Distance travelled by basket (Limit:53
57mm)

37. Q. What is In process checks?
A. In process checks are checks performed
during an activity,In order to monitor and,if
necessary,to adjust the process to ensure that
product confirms to its specification.

38. Q. What is the difference between
disintegration and dissolution?
A. Disintegration is a disaggregation process,
in which an oral dosage form falls apart in to
smaller aggregates.(Disintegration time is the
‘break up’ time of a solid dosage form).

Where as dissolution is a process by which
solid substance enters in the solvent to yield a
solution.It is controlled by the affinity between
the solid substance and the solvent.

In other word disintegration is a subset of
dissolution.

39. Q. Why do we calibrate a qualified
equipment/instrument on definite intervals?
A. An equipment or instrument can ‘drift’ out of
accuracy between the time of qualification and
actual use.So it is recommended to calibrate
and recalibrate the measuring devices and
instruments on predetermined time intervals, to
gain confidence on the accuracy of the data.

40. Q. Why do we consider three consecutive
runs/batches for process validation? Why
not two or four?
A. The number of batches produced in the
validation exercise should be sufficient to allow
the normal extent of variation and trends to be
established and to provide sufficient data for
evaluation and reproducibility.
 First batch quality is accidental (coincidental),

 Second batch quality is regular (accidental),

 Third batch quality is validation(conformation).

In 2 batch we cannot assure the reproducibility
of data,4 batches can be taken but the time
and cost are involved.

41 Q. Explain about revalidation criteria of AHU
system?
A. AHU system shall be revalidated periodically
as mentioned in the regulatory standards. AHU
shall be revalidated in following cases also.
 When basic design of AHU is changed,

 When clean room volume is changed,

 When new equipment is installed

 When a construction is carried out, that calls

for reconstruction of AHU system.

42. Q. What needs to be checked during AHU
validation?
A. During AHU validation, following tests shall
be carried out
 Filter efficiency test,

 Air velocity & number of air changes,

 Air flow pattern (visualization)

 Differential pressure, temperature and RH

 Static condition area qualification

 Dynamic condition qualification

 Nonviable count

 Microbial monitoring

 Area recovery and power failure study.

43. Q. Position of oblong tablets to be placed in
hardness tester to determine the hardness?
Lengthwise / widthwise?
A. Position of oblong tablets should be length
wise because the probability of breakage is
more in this position.

44. Q. Explain in detail about qualification of
pharmaceutical water system?
A. Qualification of pharmaceutical water system
involves three phases
 Phase 1

 Phase 2

 Phase 3

Phase 1
A test period of 24 weeks should be spent for
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 testing approach.
 Under take chemical & microbiological testing

in accordance with a defined plan.
 Sample incoming feed water daily to verify its

quality.
 Sample each step of purification process daily.

 Sample each point of use daily.

 Develop appropriate operating ranges.

 Demonstrate production and delivery of

product water of required quantity and quality.
 Use and refine the SOP’s for

operation,maintenance,sanitization and trouble
shooting.
 Verify provisional alert and action levels.

 Develop and refine test failure procedure.


Phase 2
A further test period of 24 weeks. Sampling
scheme will be same as Phase – 1.Water can
be used for 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 phase2.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 test should be reduced to the normal
routine pattern based on established
procedures proven during Phase 1 & phase
2.

45. Q. What are the recommended
environmental monitoring limits for
microbial contamination?
Description: Microbial Contamination Limits

46. Q. What is the difference between
calibration and Validation?
A. 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.

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.

In calibration performance of an instrument or
device is comparing against a reference
standard. But in validation 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).

47. Q. Briefly explain about ICH climatic zones
for stability testing & long term storage
conditions?
A.ICH STABILITY ZONES
Zone Type of Climate
Zone I Temperate zone
Zone II Mediterranean/subtropical zone
Zone III Hot dry zone
Zone Hot humid/tropical zone
IVa
Zone ASEAN testing conditions
IVb hot/higher humidity

Long term Storage condition
Climatic Temperat Humidit Minimum
Zone ure y Duration
Zone I 21ºC ± 2ºC 45% rH 12
± 5% rH Months
Zone II 25ºC ± 2ºC 60% rH 12
± 5% rH Months
Zone III 30ºC ± 2ºC 35% rH 12
± 5% rH Months
Zone IV 30ºC ± 2ºC 65% rH 12
± 5% rH Months
Zone IVb 30ºC ± 2ºC 75% rH 12
± 5% rH Months
Refrigerat 5ºC ± 3ºC No 12
ed Humidity Months
Frozen 15ºC ± No 12
5ºC Humidity Months

48. Q. What is bracketing & matrixing in
stability testing?
A.Both Matrixing & Bracketing’s are reduced
stability testing designs
Bracketing
The design of a stability schedule, such that
only samples of extremes of certain design
factors (ex:strength,package size) are tested at
all time points as in full design.The designs
assumes that the stability of any intermediate
level is represented by the stability of extremes
tested.
Matrixing
The design of a stability schedule, such that a
selected subset of possible samples for all
factor combinations is tested at a specified time
point.At a subsequent time point another
subset of samples for all factor combination is
tested.The design assumes that the stability of
each subset samples tested represents the
stability of all samples at a given time point.
There for a given time point other than initial &
final ones not every batch on stability needs to
be tested.

49. Q.What are the common variables in the
manufacturing of tablets?
A.
 Particle size of the drug substance

 Bulk density of drug substance/excipients

 Powder load in granulator

 Amount & concentration of binder

 Mixer speed & mixing timings

 Granulation moisture content

 Milling conditions

 Lubricant blending times

 Tablet hardness

 Coating solution spray rate

50. Q. Whether bracketing & validation concept
can be applied in process validation?
A.Both Matrixing & Bracketing’s can be applied
in validation studies.
Matrixing
Different strength of same product
Different size of same equipment
Bracketting Evaluating extremes
Largest and smallest fill volumes
Fastest and slowest operating speeds
Posted by Don at 09:10
17 comments:
harshadapatil9 14 October 2013 at 10:31

Very Useful Information
Reply
Replies
interview hr 30 June 2016 at 02:01
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I wonder why you didn't put change controls ,revisions
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You can expect new posts in this regard in a week's time or so.
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information is good
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আরও পরবত গ» mduseu@gmail.com ড াশেবাড ান ক ন

Wednesday, 25 January 2012 About Me

original container requires any stability

number of air changes in an area?

Posted by Don at 09:10

harshadapatil9 14 October 2013 at 10:31

interview hr 30 June 2016 at 02:01

Tks very much for your post.

Source: Download Ebook: Ultimate Guide To Job Interview Questions Answers:

jeenoor pavan 19 January 2014 at 19:37

Don 20 January 2014 at 06:11

Kiran Tankala 10 March 2014 at 03:16

Baljit Bangar 10 March 2014 at 13:39

great help thanx

Rajesh Kumar 13 March 2014 at 11:18

Its helps us alot

Sangeetha Edunuri 22 March 2014 at 09:10

Deepika Sharma 6 January 2016 at 23:12

Martina Johan 21 June 2016 at 10:41

Martina Johan 21 June 2016 at 10:48

Unknown 5 July 2016 at 08:28

Alamin Miah 1 February 2017 at 19:47

Alamin Miah 18 March 2017 at 23:36

Mona afrin 29 March 2017 at 03:15

Mona afrin 8 April 2017 at 02:12

Pradeep Singh 8 June 2017 at 23:30

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