Interview Questions.

Top 100+ Pharmaceutical Quality Assurance Interview Questions And Answers

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Top 100+ Pharmaceutical Quality Assurance Interview Questions And Answers

Question 1. What Is An Sop ?

Answer :

Standard Operating Procedure (SOP) is a positive kind of document that describes in a step-via-step 

Question 2. What Is 21 Cfr Part eleven ?

Answer :

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) hints on digital data and digital signatures within the United States. Part eleven, as it's far normally known as, defines the criteria under which digital facts and electronic signatures are considered to be straightforward, reliable and equal to paper statistics.

Medical Terminology(Adaptive*) Interview Questions
Question 3. What Are User Requirements ?

Answer :

User Requirements Specification describes what customers require from the System. User requirement specs are written early in the validation system, generally earlier than the machine is created. It is written by means of the System Owner and End Users, with input from Quality Assurance. Requirements mentioned inside the URS are usually tested within the Performance Qualification. User Requirements Specifications are not meant to be a technical document; readers with most effective a fashionable information of the machine ought to be capable of understand the necessities mentioned in the URS.

Question four. What Is A Validation Plan ?

Answer :

Validation Plans outline the scope and goals of a validation mission. Validation plans are written earlier than a validation challenge and are particular to a single validation task.

Validation Plans can encompass:

Deliverables (Documents) to be generated in the course of the validation system
Resources/Departments/Personnel to participate in the validation venture
Time-Line for completing the validation venture
Medical Terminology(Adaptive*) Tutorial
Question five. What Is An Iq Document ?

Answer :

Installation Qualifications are a group of check cases used to affirm the proper installation of a System. The requirement to correctly deploy the gadget changed into described inside the Design Specification. Installation Qualifications have to be done before completing Operational Qualification and Performance Qualification.

Pharmacology Interview Questions
Question 6. What Is An Oq Document ?

Answer :

Operational Qualifications are a group of check instances used to affirm the right functioning of a System. The operational qualification exams necessities described within the Functional Requirements. Operational Qualifications are usually performed earlier than the machine is released to be used.

Question 7. What Is A Pq Document ?

Answer :

Performance Qualifications are a collection of check cases used to affirm that a System performs as expected beneath simulated real-global conditions. The performance qualification assessments requirements that were described in the User Requirement Specification (or probably the Functional Requirements). Due to the nature of overall performance qualifications, these assessments are sometime carried out with strength users because the gadget is being released.

Pharmacology Tutorial Clinical Research Interview Questions
Question 8. What Is A Validation Summary Report ?

Answer :

Validation Summary Reports offer an outline of the complete validation venture. When regulatory auditors evaluate validation tasks, they usually begin by means of reviewing the summary report.

The validation summary document ought to consist of:

A description of the validation task
All check instances executed, consisting of if those take a look at cases handed without trouble
All deviations said, which includes how the ones deviations had been resolved
Question nine. What Is A Change Request ?

Answer :

Change Control is a general term describing the technique of dealing with how adjustments are delivered into a controlled System. In validation, this means how modifications are made to the tested device. Change control is required to demonstrate to regulatory authorities that validated systems remain underneath control after machine adjustments. Change Control systems are a favourite target of regulatory auditors because they vividly reveal an business enterprise capability to control its structures.

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

Answer :

Water is a first-rate medium for plenty microorganisms, microorganism can be a noticeably pathogenic which causes severe sicknesses(many illnesses are  water born), these pathogens infect after consumption of infected water, microorganisms tend to decide a floor if water is authorized to face in a stagnant role for few hours, those settled microorganism form a movie over the floor of vessel and piping, such film shaped through microorganisms is also referred to as as biofilm, biofilms are very hard of remove, as soon as a biofilm is formed at a specific point then that factor may also form a biofilm once more even after cleansing very without difficulty as seed from this point is might not absolutely get removed correctly.

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 nice medium for many microorganisms, microorganism can be a distinctly pathogenic which causes severe illnesses(many illnesses are  water born), these pathogens infect after intake of contaminated water, microorganisms have a tendency to come to a decision a surface if water is allowed to stand in a stagnant role for few hours, those settled microorganism form a movie over the floor of vessel and piping, such film fashioned by way of microorganisms is likewise referred to as as biofilm, biofilms are very hard of get rid of, once a biofilm is fashioned at a particular point then that factor may additionally form a biofilm once more even after cleaning very effortlessly as seed from this factor is won't absolutely get removed correctly.

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 unfastened from inorganic in addition to natural 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 exceptionally energetic they take part in nucliophylic substitution reactions, in which in they destroy a double bond among -C=C- in to a unmarried bond as CL –CH-CH2- , which a motive why we look at that colour dies tend to fed in presence of chlorine as maximum of the dies used are diazo compounds which has masses of locations for nucliophylic substitution reactions, which is also a reason why balance of drug is considerably affected in presence of cations and anions from mineral beginning 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 tremendously cumulative neurotoxic metals, heavy metals aren't eliminated out of our body without problems like other capsules and molecules but heavy metals bind with proteins and tend to get accrued in fatty tissues, nerve tissue is maximum possibly to get damaged through heavy metals, heavy metal causes nervous tissue harm there for water ought to be loose 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 within the length or form of the authentic field may not necessitate the initiation of latest balance examine.

Pharmacist Interview Questions
Question 16. Forced Degradation(strain Testing) And Accelerated Stability Testing Are Same?

Answer :

Forced degradation and stress trying out aren't same. Stress trying out is possibly to be carried out on a unmarried batch of the drug substance. The trying out need to encompass the effect of temperatures (in 10°C increments (e.G., 50°C, 60°C) above that for extended testing), humidity (e.G., 75 percent relative humidity or extra) where suitable, oxidation, and photolysis on the drug substance. The testing have to also examine the susceptibility of the drug substance to hydrolysis across a extensive range of pH values while in answer or suspension. Photo balance testing should be an critical part of stress checking out.

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 (warm and humid international locations)

Zone IV b: 30°C and 75% RH (hot and very humid international locations

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 assist discover the probable degradation merchandise, which can in flip help establish the degradation pathways and the intrinsic balance of the molecule and validate the stableness indicating power of the analytical methods used. The nature of the strain testing will rely upon the person drug substance and the sort of drug product concerned.

Question 20. What Is Dead Leg?

Answer :

A useless leg is described as a place in a piping system in which liquid can emerge as stagnant and now 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 endorsed bioburden restriction 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 & merchandise

Question 23. What Is Significant Changes In Stability Testing?

Answer :

A 5% trade in assay for initial fee.

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

Answer :

Immediately prevent packing procedure and take a look at for:

Sealing temperature                 
Verify for any viable adjustments like foil width,knurling and so on.
Check & quarantine the isolated amount of packed items from final passed inprocess.
Collect random samples & do retest.
Blisters from the leak take a look at surpassed packing containers shall permit to go further and relaxation have to be deblistered/defoiled for this reason.
Clinical Research Interview Questions
Question 25. How Many Tablets Shall Be Taken For Checking Friability?

Answer :

For tablets with unit mass equal or much less than 650 mg, take  sample of entire capsules corresponding to 6.

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

Answer :

Generally the take a look at is administered for as soon as.If any cracked,cleaved or damaged capsules present within the tablet pattern after tumbling,the capsules fails the check.If the consequences are doubtful,or weight reduction is grater than the focused value,the test should be repeated two times and the imply of the 3 assessments decided.A  imply weight loss from the 3 samples of not extra than 1.Zero% is considered applicable for most of the goods.

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

Answer :

one hundred 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 8 in every turn inside the equipment.

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

Answer :

To determine need for the pressure changes on the tableting machine. Hardness can have an effect on the disintegration time.If pill is just too hard, it may no longer fall apart inside the required period of time. And if pill is simply too soft it will not resist coping with and subsequent processing which includes coating,packing etc.

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

Answer :

compression force
Binder quantity(More binder extra hardness)
Moisture content material
Question 31. Which Type Of Tablets Are Exempted From Disintegration Testing?

Answer :

Chewable Tablets

Question 32. Which Capsule Is Bigger In Size - Size 'zero' 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/tablets fails to crumble absolutely, repeat the check on any other 12 additional dosage units. The requirement is meet if now not fewer than sixteen out of 18 tablets/drugs tested are disintegrated absolutely.

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  of the man or woman weights can deviates from the average weight by using more than the proportion given inside 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 infection of the product being sampled (Don’t collect samples with bare arms) & avoid  contamination of pattern taken.

Paramedic Interview Questions
Question forty one. In A Tablet Manufacturing Facility ‘high quality’ Pressure Is Maintained In Processing Area Or Service Corridors?

Answer :

In tablet manufacturing facilities, stress gradients are maintained to keep away from pass contamination of products through air. Usually processing areas are maintained beneath nice stress with admire to provider corridors.

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

Answer :

If the granules are not dried well sticking can occur.
Too little or wrong lubrication also can ends in sticking.
Sticking can  occur due to an excessive amount of binder or hygroscopic granular.
Clinical Laboratory Technician Interview Questions
Question forty three. What Checks Shall Be Carried Out, While Calibrating Dt Apparatus?

Answer :

While calibrating DT apparatus, following tests will be completed.

Question 44. What Is In Process Checks?

Answer :

In technique checks are  assessments executed for the duration of an hobby,In order to monitor and,if important,to alter 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 procedure, wherein an oral dosage shape falls apart in to smaller aggregates.(Disintegration time is the ‘cut up’ time of a strong dosage form).
Where as dissolution is a method by using which stable substance enters inside the solvent to yield a solution.It is managed by the affinity among the stable substance and the solvent.
In other phrase disintegration is a subset of dissolution.
Question forty six. Why Do We Calibrate A Qualified Equipment/instrument On Definite Intervals?

Answer :

An system or instrument can ‘glide’ out of accuracy between the time of qualification and real use.So it's miles endorsed to calibrate and recalibrate the measuring devices and devices on predetermined time durations, to benefit self assurance at the accuracy of the records.

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

Answer :

The number of batches produced within the validation exercise ought to be enough to allow the normal extent of variation and developments to be established and to offer sufficient data for evaluation and reproducibility.

First batch great is unintended (co-incidental),
Second batch excellent is normal (unintentional),
Third batch pleasant is validation(conformation).
In 2 batch we can not guarantee the reproducibility of statistics,4 batches can be taken but the time and cost are worried.

Question forty eight. Explain About Revalidation Criteria Of Ahu System?

Answer :

AHU machine will be revalidated periodically as stated in the regulatory requirements.

AHU shall be revalidated in following cases also:

When primary design of AHU is changed,
When clean room quantity is changed,
When new system is established
When a production is carried out, that requires reconstruction of AHU gadget.
Question 49. What Needs To Be Checked During Ahu Validation?

Answer :

During AHU validation, following assessments will be finished:

Filter efficiency test,
Air velocity & quantity of air modifications,
Air float pattern (visualization)
Differential strain, temperature and RH
Static condition place qualification
Dynamic circumstance qualification
Non-viable be counted
Microbial monitoring
Area recovery and electricity failure examine.
Question 50. Position Of Oblong Tablets To Be Placed In Hardness Tester To Determine The Hardness? Lengthwise / Widthwise?

Answer :

Position of rectangular pills need to be length smart because the chance of breakage is more in this role.

Question 51. Explain In Detail About Qualification Of Pharmaceutical Water System?

Answer :

Qualification of pharmaceutical water machine includes three stages:

Phase -1
Phase -2
Phase -3
Phase -1:

A test period of 2-four weeks must be spent for tracking the device intensively. During this era the machine should perform constantly without failure or overall performance deviation.Water can not be used for pharmaceutical production on this segment.The following need to be included in checking out method.

Under take chemical & microbiological testing according with a described plan.
Sample incoming feed water each day to affirm its quality.
Sample every step of purification technique each day.
Sample each point of use daily.
Develop appropriate running tiers.
Demonstrate manufacturing and transport of product water of required amount and satisfactory.
Use and refine the SOP’s for operation,maintenance,sanitization and problem capturing.
Verify provisional alert and motion ranges.
Develop and refine test failure method.
Phase -2:

A further take a look at period of 2-four weeks. Sampling scheme might be same as  Phase – 1.Water can be used for manufacturing method in this phase. Approach have to additionally

Demonstrate consistent operation within hooked up tiers.
Demonstrate regular production & delivery of water of required great and quantity.
Phase - 3:

Phase three runs for twelve months after pleasant finishing touch of phase-2.Water can be used for production process at some stage in this method.

Objectives & Features of Phase -3:

Demonstrate giant dependable overall performance.
Ensure that seasonal versions are evaluated.
The pattern locations, sampling frequencies and test must be decreased to the regular routine sample primarily based on hooked up procedures demonstrated at some point of Phase -1 & phase - 2.
Question fifty two. What Is The Difference Between Calibration And Validation?

Answer :

Calibration is an illustration that, a particular
Instrument or device produces effects with in distinct limits by means of comparisons with the ones produced with the aid of a reference or traceable widespread over the precise range of measurements.
Where as Validation is a documented program that provides excessive diploma of guarantee that a selected process, technique or system constantly produces a end result meeting pre-decided attractiveness criteria.
In calibration performance of an tool or tool is comparing against a reference popular. But in validation such reference preferred isn't using.
Calibration ensures that tool or measuring devices generating correct outcomes. Whereas validation demonstrates that a procedure, system, method or machine produces steady results (in other words, it ensures that uniforms batches are produced).
Question fifty three. Briefly Explain About Ich Climatic Zones For Stability Testing & Long Term Storage Conditions?

Answer :

ICH STABILITY ZONES:

Zone: Type of Climate

Zone I: Temperate region

Zone II: Mediterranean/subtropical quarter

Zone III: Hot dry sector

Zone IVa: Hot humid/tropical zone

Zone IVb:

ASEAN trying out conditions hot/higher humidity
Long time period 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

sixty five% rH ± 5% rH

12 Months

Zone IVb:

30ºC ± 2ºC

seventy five% rH ± 5% rH

12 Months

Refrigerated

5ºC ± 3ºC

No Humidity

12 Months

Frozen

-15ºC ± 5ºC

No Humidity

12 Months

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

Answer :

Particle length of the drug substance:

Bulk density of drug substance/excipients
Powder load in granulator
Amount & concentration of binder
Mixer velocity & mixing timings
Granulation moisture content material
Milling conditions
Lubricant mixing instances
Tablet hardness
Coating solution spray charge
Question fifty five. Whether Bracketing & Validation Concept Can Be Applied In Process Validation?

Answer :

Both Matrixing and Bracketing can be applied in validation research.
Matrixing
Different electricity of equal product
Different length of equal system
Bracketing - Evaluating extremes   
Largest and smallest fill volumes
Fastest and slowest running speeds




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