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Question 1. What Is An Sop ?

Answer :

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

Question 2. What Is 21 Cfr Part 11 ?

Answer :

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration
(FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is
commonly called, defines the criteria under which electronic records and electronic signatures are
considered to be trustworthy, reliable and equivalent to paper records.

Medical Terminology(Adaptive*) Interview Questions

Question 3. What Are User Requirements ?

Answer :

User Requirements Specification describes what users require from the System. User requirement
specifications are written early in the validation process, typically before the system is created. It is
written by the System Owner and End Users, with input from Quality Assurance. Requirements
outlined in the URS are usually tested in the Performance Qualification. User Requirements
Specifications are not intended to be a technical document; readers with only a general knowledge
of the system should be able to understand the requirements outlined in the URS.

Question 4. What Is A Validation Plan ?

Answer :

Validation Plans define the scope and goals of a validation project. Validation plans are written
before a validation project and are specific to a single validation project.

Validation Plans can include:

Deliverables (Documents) to be generated during the validation process

Resources/Departments/Personnel to participate in the validation project

Time-Line for completing the validation project

Medical Terminology(Adaptive*) Tutorial

Question 5. What Is An Iq Document ?

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

Pharmacology Interview Questions

Question 6. What Is An Oq Document ?

Answer :

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

Question 7. What Is A Pq Document ?

Answer :

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

Pharmacology Tutorial Clinical Research Interview Questions

Question 8. What Is A Validation Summary Report ?

Answer :

Validation Summary Reports provide an overview of the entire validation project. When regulatory
auditors review validation projects, they typically begin by reviewing the summary report.

The validation summary report should include:

A description of the validation project

All test cases performed, including if those test cases passed without issue

All deviations reported, including how those deviations were resolved

Question 9. What Is A Change Request ?

Answer :

Change Control is a general term describing the process of managing how changes are introduced
into a controlled System. In validation, this means how changes are made to the validated system.
Change control is required to demonstrate to regulatory authorities that validated systems remain
under control after system changes. Change Control systems are a favorite target of regulatory
auditors because they vividly demonstrate an organization capacity to control its systems.

Medical Cardiology Interview Questions

Question 10. Why Water For Pharmaceutical Use Is Always Kept In Close Loop In Continuous
Circulation?

Answer :

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.

Question 11. 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.

Answer :

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.

Medical School Interview Questions

Question 12. Water For Pharmaceutical Use Shall Be Free Cations,anions And Other Impurities Why ?

Answer :

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 –
CH-CH2- , 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.

Medical Terminology(Adaptive*) Interview Questions

Question 13. Water For Pharmaceutical Use Shall Be Free Heavy Metals Why ?

Answer :

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.
Question 14. Brazil Falls Under Which Climatic Zone ?

Answer :

Zone IVB (30 degree celsius and 75% relative humidity)

Question 15. Change In The Size Or Shape Of The Original Container Requires Any Stability Study?

Answer :

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

Pharmacist Interview Questions

Question 16. Forced Degradation(stress Testing) And Accelerated Stability Testing Are Same?

Answer :

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.

Question 17. According To Who Guidelines What Is The Storage Condition Of Climatic Zone Iva And
Zone Ivb?

Answer :

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

Paramedic Interview Questions

Question 18. Countries Comes Under Climatic Zone Ivb?

Answer :

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

Pharmacology Interview Questions

Question 19. 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. The nature of the stress testing will
depend on the individual drug substance and the type of drug product involved.
Question 20. 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.

Clinical Laboratory Technician Interview Questions

Question 21. What Is The Recommended Bio Burden Limits Of Purified Water & Wfi?

Answer :

Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection (WFI) has
a recommen

Question 22. Brief About Ich Stability Guidelines?

Answer :

Q1A- Stability testing of new drug substance & products

Question 23. What Is Significant Changes In Stability Testing?

Answer :

A 5% change in assay for initial value.

Question 24. If Leak Test Fail During In Process Checks What Needs To Be Done ?

Answer :

Immediately stop packing process and check for:

Sealing temperature

Verify for any possible changes like foil width,knurling etc.

Check & quarantine the isolated quantity of packed goods from last passed inprocess.

Collect random samples & do retest.

Blisters from the leak test passed containers shall allow to go further and rest must be
deblistered/defoiled accordingly.

Clinical Research Interview Questions

Question 25. 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 26. What Is The Pass Or Fail Criteria For Friability Test?

Answer :
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.

Question 27. What Is The Standard Number Of Rotations Used For Friability Test?

Answer :

100 rotations

Medical Cardiology Interview Questions

Question 28. What Is The Fall Height Of The Tablets In The Friabilator During Friability Testing?

Answer :

6 inches.Tablets falls from 6 inches eight in each turn within the apparatus.

Question 29. Why Do We Check Hardness During Inprocess Checks?

Answer :

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.

Question 30. What Are The Factors Which Influence Tablet Hardness?

Answer :

compression force

Binder quantity(More binder more hardness)

Moisture content

Question 31. Which Type Of Tablets Are Exempted From Disintegration Testing?

Answer :

Chewable Tablets

Question 32. Which Capsule Is Bigger In Size - Size '0' Or Size '1'?

Answer :

'0' size

Question 33. What Is The Recommended Temperature For Checking Dt Of A Dispersible Tablet?

Answer :

25 ±10C (IP) & 15 – 250C (BP)

Medical School Interview Questions

Question 34. What Is Mesh Aperture Of Dt Apparatus ?

Answer :

1.8 -2.2mm (#10)

Question 35. What Is The Pass/fail Criteria For Disintegration Test?

Answer :

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.

Question 36. What Is The Recommended Storage Conditions For Empty Hard Gelatin Capsules?

Answer :

15 - 250C & 35 -55% RH

Pharmacist Interview Questions

Question 37. Which Method Is Employed For Checking “uniformity Of Dosage Unit”?

Answer :

Content uniformity

Question 38. What Is The Recommended Upward And Downward Movement Frequency Of A
Basket-rack Assembly In A Dt Apparatus?

Answer :

28 – 32 cycles per minute.

Question 39. When Performing The ‘uniformity Of Weight’ Of The Dosage Unit, How Many
Tablet/capsule Can Deviate The Established Limit?

Answer :

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.

Question 40. What Precautions Shall Be Taken While Collecting In Process Samples ?

Answer :

While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect
samples with bare hands) & avoid contamination of sample taken.

Paramedic Interview Questions

Question 41. In A Tablet Manufacturing Facility ‘positive’ Pressure Is Maintained In Processing Area
Or Service Corridors?
Answer :

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.

Question 42. If Sticking Observed During Tablet Compression What May The Probable Reason For
The Same?

Answer :

If the granules are not dried properly sticking can occur.

Too little or improper lubrication can also leads to sticking.

Sticking can occur because of too much binder or hygroscopic granular.

Clinical Laboratory Technician Interview Questions

Question 43. What Checks Shall Be Carried Out, While Calibrating Dt Apparatus?

Answer :

While calibrating DT apparatus, following checks shall be performed.

Question 44. What Is In Process Checks?

Answer :

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.

Question 45. What Is The Difference Between Disintegration And Dissolution?

Answer :

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.

Question 46. Why Do We Calibrate A Qualified Equipment/instrument On Definite Intervals?

Answer :

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.

Question 47. Why Do We Consider Three Consecutive Runs/batches For Process Validation? Why
Not Two Or Four?

Answer :
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 (co-incidental),

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.

Question 48. Explain About Revalidation Criteria Of Ahu System?

Answer :

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.

Question 49. What Needs To Be Checked During Ahu Validation?

Answer :

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

Non-viable count

Microbial monitoring

Area recovery and power failure study.

Question 50. Position Of Oblong Tablets To Be Placed In Hardness Tester To Determine The
Hardness? Lengthwise / Widthwise?

Answer :

Position of oblong tablets should be length wise because the probability of breakage is more in this
position.
Question 51. 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 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 2-4 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 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 test should be reduced to the normal routine
pattern based on established procedures proven during Phase -1 & phase - 2.
Question 52. 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.

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).

Question 53. 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:

21ºC ± 2ºC

45% rH ± 5% rH

12 Months
Zone II:

25ºC ± 2ºC

60% rH ± 5% rH

12 Months

Zone III:

30ºC ± 2ºC

35% rH ± 5% rH

12 Months

Zone IV:

30ºC ± 2ºC

65% rH ± 5% rH

12 Months

Zone IVb:

30ºC ± 2ºC

75% rH ± 5% rH

12 Months

Refrigerated

5ºC ± 3ºC

No Humidity

12 Months

Frozen

-15ºC ± 5ºC

No Humidity

12 Months

Question 54. What Are The Common Variables In The Manufacturing Of Tablets?

Answer :

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

Question 55. 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 same product

Different size of same equipment

Bracketing - Evaluating extremes

Largest and smallest fill volumes

Fastest and slowest operating speeds

They may expect answers structure you for other HPLC, UV and so on standards technique
moreover. For your comprehension about QA employment and learning required for this activity, we
have given QA work arranged information related inquiries here.

Quality Assurance Interview Questions in pharma industry are as per the following

General Quality Assurance Interview Questions in pharma industry:

 Introduce yourself

 Tell me about yourself

 Your strength and weakness

 Why do you want to join us?

 How long will you stay with our company?.

 Your achievements

 Are you planning for further studies?

 Do you know any one in this company?

 Are you fresher or experienced?

 Your work experience?

 Why should we hire you for this job?

 What salary are you looking for?

  Why you left the previous job (if experienced)?

 What type of major challenges and problems have you faced?

 Where do you see yourself in 5 years?

Technical Quality Assurance Interview Questions in pharma industry

 Define quality assurance

 Difference Between Quality assurance and Quality control

 What is cGMP?

 Difference between cGMP and GMP

 ICH Guidelines

 Difference between validation and calibration

 What is IQ OQ PQ DQ

 Cleaning validation

 Some times they will ask you principle of various instruments and equipments such as HPLC,
GC UV etc., so just go through it.

 Standard Operation Procedure general questions (what is SOP, type of SOP? etc.,)

 General questions on BMR

 General question on BPR

 Types of Regulatory bodies.

 How many guidelines do you know?

 Have you ever faced audit?

 What is audit?

 Types of audit?

 What is deviation?

 What is Out of specification or Out of trend?

 Sampling procedure

 Sampling methods.

 In process quality control test.

 Stability studies, short term and long term.

 Stability or climatic zones.

 Water validation phase I , II and III time period.

 How to do Swab analysis?

  HVAC system general questions.

These are some of the questions which they will ask you, but if you are experienced person , then
they will ask you about your previous work,

 What type of work you have done in your previous organization?

 Which type of work , you will perform better.

Reminder Points:

1. Dont try to give wrong answers, if you do not know the answer then tell them frankly , that
you dont know the answer.

2. In walk in interview sometimes they are taking written test to shortlist the candidates.

3. If you answer wrong then they will ask you more about that particular topic.

4. Before going to any company for interview, just make a list that what type of products they
are manufacturing, for example, if they are manufacturing tablets, capsules or parental
products, then go through some basic questions such as ,. types of defects in tablets, ph of
parental products, or capsule is made up of? etc,.

Quality Assurance Interview Questions

Q. Define quality assurance

Ans) QA is a broad range of concept contains all the matters that individually or collectively effect
the quality of a product. QA mainly concentrated on planning and documenting the procedures to
assure the quality of the product.

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
selfsanitizing, 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.

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 –
CH-CH2- , 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.

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.

Q. Brazil falls under which climatic zone ?

A. Zone IVB (30 degree celsius and 75% relative humidity)

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.

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.

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

Q. Countries comes under climatic zone IVb?

A.Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Thailand

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.

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.

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.

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.

Q. Brief about ICH stabilty guidelines?

A. Q1A- Stability testing of new drug substance & products

Q1B- Photo stability testing of new drug substances & products

Q1C-Stability testing of new dosage forms

Q1D-Bracketing & Matrixing designs for testing of new drug substances and products

Q1E-Evaluation of stability data

Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)

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.

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

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.

Quality Assurance Interview Questions

Q. What is the formula for calculating weight loss during friability test?

A. %Weight loss = Initial Weight – Final Weight X 100 Initial Weight

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 greater
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.

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

A. 100 rotations

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.

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.

Q. What are the factors which influence tablet hardness?

A. 1.compression force

2.Binder quantity(More binder more hardness)

3.Moisture content

Q. Which type of tablets are exempted from Disintegration testing?

A. Chewable Tablets

Q. Which capsule is bigger in size – size ‘0’ or size ‘1’?

A. ‘0’ size

Q. What is the recommended temperature for checking DT of a dispersible tablet?

A. 25 ±10C (IP) & 15 – 250C (BP)

Q. What is mesh aperture of DT apparatus ?

A. 1.8 -2.2mm (#10)

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.

Q. What is the recommended storage conditions for empty hard gelatin capsules?

A. 15 – 250C & 35 -55% RH

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.

Q. What is the recommended upward and downward movement frequency of a basket-rack

assembly in a DT apparatus?

A. 28 – 32 cycles per minute.

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

or Less than

250mg

7.5% 130mg to 324mg

250mg or more 5% More than 324mg

Weight Variation limits for Capsules

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.)

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.
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.

Quality Assurance Interview Questions

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.

Q. Explain the difference between QC and QA?

Ans) QA provides the confidence that a product will full fill the quality requirements. QC determines
and measures the product quality level.

Q. Expand cGMP and what is the difference between GMP and cGMP?

Ans) cGMP known as Current Good Manufacturing Practices. It is a USFDA regulations to assure
proper design , manufacturing and control of manufacturing processes and services.

GMP-Good Manufacturing Practices. These are the standard guidelines given by Food and Drug
administration to make sure that a product is manufactured with safety and quality. c
in cGMP means current. It refers to recent and advance updates to these standard guidelines.
cGMP is up to date standard reference guidelines.

Q) Tell me any five countries with their regulatory authorities?

Ans) India – Central Drugs Standard Control Organisation (CDSCO)

USA – United States Food and Drug Administation (USFDA)

UK – Medicines and Healthcare products Regulatory Agency (MHRA)

Japan- Ministry of Health Labour and Welfare (MHLW)

Australia- Therapeutics Goods Administration (TGA)

Brazil- ANVISA

Q) Expand ICH? Tell me about ICH Guidelines?

ICH known as The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use. It brings the regulatory authorities and pharmaceutical companies
together to discuss the drug registration technical aspects.

The aim of the ICH is to enhance the harmonisation world wide to make sure that safe, high quality
and effective drugs are developed and registered in the most efficient manner.

ICH provides guidelines on 4 aspects that is quality , safety , Efficacy and Multidisciplinary guidelines.

Q) What is SOP?
SOP known as Standard Operating Procedure.

Q)Expand IQ OQ PQ DQ

IQ- Installation Qualification

OQ-Operational Qualification

PQ-Performance Qualification

DQ-Design Qualification

Q) Difference between validation and calibration

Validation produces the documented evidence assuring a specific procedure/procedure or activity

consistently develops a product with predetermined specifications and quality credits. It is
performed according to validation protocol.

Calibration denotes that an equipment produces the values in specified limits by comparing the
values produced by a standard. It is done according the calibration standard operating procedure.

Q) Expand BMR and BPR?

Ans) BMR – Batch Manufacturing Record , is prepared as a written file during the manufacturing a
product by writing. Step by step manufacturing process and details about batch recorded here.

BPR Batch Packaging Record, is kept for every BMR. BPR is depends on packaging operation.

Q) What do you know about stability studies?

Ans) These are necessary for developing the pharmaceutical products. It helps to evaluate the effect
of environmental factors (e.g Light, Humidity, Temperature etc) on Active Pharmaceutical
Ingredient(API) or Pharmaceutical formulation.

Q) What is the time period required for long term and accelerated stability studies?

Ans) Long term 12 months, Accelerated studies- 6 months

Q) What are types of climatic zones? India belongs to which climatic zone?

Ans) India belongs to Zone III(Hot dry zone) and Zone IVb(Hot/Higher humidity)

Q. What is an SOP ?

A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step
outline form how to perform a particular task or operation. Everyone in a company must follow the
same procedures to assure that tasks are performed consistently and correctly. Most companies
have a wide variety of SOPs that describe how to do different tasks. In many companies technicians
and operators are trained in how to follow individual SOPs and their training record specifies which
SOPs they are trained on and are authorized to use.

Q. What is 21 CFR part 11 ?

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration
(FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is
commonly called, defines the criteria under which electronic records and electronic signatures are
considered to be trustworthy, reliable and equivalent to paper records
Q. What are user requirements ?

User Requirements Specification describes what users require from the System. User requirement
specifications are written early in the validation process, typically before the system is created. It is
written by the System Owner and End Users, with input from Quality Assurance. Requirements
outlined in the URS are usually tested in the Performance Qualification. User Requirements
Specifications are not intended to be a technical document; readers with only a general knowledge
of the system should be able to understand the requirements outlined in the URS.

Q. What is a validation plan ?

Validation Plans define the scope and goals of a validation project. Validation plans are written
before a validation project and are specific to a single validation project. Validation Plans can
include:

Deliverables (Documents) to be generated during the validation process

Resources/Departments/Personnel to participate in the validation project

Time-Line for completing the validation project

Q. What is an IQ document ?

Installation Qualifications are a collection of test cases used to verify the proper installation of a
System. The requirement to properly install the system was defined in the Design Specification.
Installation Qualifications must be performed before completing Operational Qualification or
Performance Qualification.

Quality Assurance Interview Questions

Q. What is an OQ Document ?

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

Q. What is a PQ Document ?

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

Q. What is a Validation Summary Report ?

Validation Summary Reports provide an overview of the entire validation project. When regulatory
auditors review validation projects, they typically begin by reviewing the summary report. The
validation summary report should include:

A description of the validation project

All test cases performed, including if those test cases passed without issue

All deviations reported, including how those deviations were resolved

Q. What is a Change Request ?

Change Control is a general term describing the process of managing how changes are introduced
into a controlled System. In validation, this means how changes are made to the validated system.
Change control is required to demonstrate to regulatory authorities that validated systems remain
under control after system changes. Change Control systems are a favorite target of regulatory
auditors because they vividly demonstrate an organization capacity to control its systems.

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.

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 –
CH-CH2- , 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.

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.

Q. Brazil falls under which climatic zone ?

A. Zone IVB (30 degree celsius and 75% relative humidity)

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.

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.

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

Q. Countries comes under climatic zone IVb?

A.Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Thailand

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.

Quality Assurance Interview Questions

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.

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.

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.

Q. Brief about ICH stabilty guidelines?

A. Q1A- Stability testing of new drug substance & products

Q1B- Photo stability testing of new drug substances & products

Q1C-Stability testing of new dosage forms

Q1D-Bracketing & Matrixing designs for testing of new drug substances and products

Q1E-Evaluation of stability data

Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)

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.

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.

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.

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

Initial Weight

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.

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

A. 100 rotations

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.

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.

Q. What are the factors which influence tablet hardness?

A.

1.compression force

2.Binder quantity(More binder more hardness)

3.Moisture content

Q. Which type of tablets are exempted from Disintegration testing?

A. Chewable Tablets

Q. Which capsule is bigger in size – size ‘0’ or size ‘1’?

A. ‘0’ size

Q. What is the recommended temperature for checking DT of a dispersible tablet?

A. 25 ±10C (IP) & 15 – 250C (BP)

Q. What is mesh aperture of DT apparatus ?

A. 1.8 -2.2mm (#10)

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.
Q. What is the recommended storage conditions for empty hard gelatin capsules?

A. 15 – 250C & 35 -55% RH

Quality Assurance Interview Questions

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.

Q. What is the recommended upward and downward movement frequency of a basket-rack

assembly in a DT apparatus?

A. 28 – 32 cycles per minute.

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 or Less than 250mg

7.5%

130mg to 324mg

250mg or more

5%

More than 324mg

Weight Variation limits for Capsules

IP

Limit
Less than 300mg

10%

300mg or More

7.5%

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.)

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.

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.

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.

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)

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.

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.

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.

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 (co-incidental),

· 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.

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.

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

· Non-viable count

· Microbial monitoring

· Area recovery and power failure study.

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.

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 2-4 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 2-4 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 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 test should be reduced to the normal routine
pattern based on established procedures proven during Phase -1 & phase – 2.

Q. What are the recommended environmental monitoring limits for microbial contamination?

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).

Quality Assurance Interview Questions

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 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

21ºC ± 2ºC

45% rH ± 5% rH

12 Months

Zone II

25ºC ± 2ºC

60% rH ± 5% rH

12 Months

Zone III

30ºC ± 2ºC

35% rH ± 5% rH

12 Months

Zone IV

30ºC ± 2ºC

65% rH ± 5% rH

12 Months

Zone IVb

30ºC ± 2ºC

75% rH ± 5% rH

12 Months

Refrigerated
5ºC ± 3ºC

No Humidity

12 Months

Frozen

-15ºC ± 5ºC

No Humidity

12 Months

Q. What is bracketing & matrixing in stability testing?

Ans.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.

Q.What are the common variables in the manufacturing of tablets?

Ans.

· 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

Q. Whether bracketing & validation concept can be applied in process validation?

Ans.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