Pharmacology Interview Questions
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| pharmaceutical interview questions and answers |
Answer :
- NCPDP is a National Council for Prescription Drug Program before anything is started; a pharmacy needs to sign up with NCPDP, a database service which allows to the bill. NCPDP issues a unique number to each pharmacy that identifies it for billing purposes
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Answer :
- PBM stands for Pharmacy Benefits Manager; it is often a third-party administrator of prescription drug programs but sometimes can be a service inside of an integrated health care system It is responsible for processing and paying prescription drugs.
Clinical Laboratory Technician Interview Questions
Q103- Why Pharmacist Insurance Is Important?Answer :
- It is more often that in case of any critical situation, doctors are sued by patients, but there are still chances that even pharmacist can be dragged. So insurance can help you pay for your legal defense and can protect your license rights.
Question 104- What Is An Sop?
Answer :
Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step
Question 105- 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.
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Medical Terminology(Adaptive*) Interview Questions
Question106- 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.
Question107- 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
Question108- 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 109- 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 110- 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 sometimes conducted with power users as the system is being released.
Pharmacology Tutorial Clinical Research Interview Questions
Question 111- 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 112- 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. Invalidation, 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 organizational capacity to control its systems.
Medical Cardiology Interview Questions
Question 113- Why Water For Pharmaceutical Use Is Always Kept In Closed Loop In Continuous Circulation?
Answer :
- Water is the best medium for many microorganisms, microorganism can be 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 a few hours, this settled microorganism forms a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult to 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 114- 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 the best medium for many microorganisms, microorganism can be 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 a few hours, this settled microorganism forms a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult to 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 115- 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 nucleophilic substitution reactions, wherein 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 to tend to fed in presence of chlorine as most of the dies used are diazo compounds which has plenty of places for nucleophilic 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 116- 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 117- Brazil Falls Under Which Climatic Zone ?
Answer :
Zone IVB (30-degree celsius and 75% relative humidity)
Question 118- 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 the new stability study.
Pharmacist Interview Questions
Question 119- Forced Degradation(stress Testing) And Accelerated Stability Testing Are Same?
Answer :
- Forced degradation and stress testing are not the 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 10C increments (e.g., 50C, 60C) 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. Photostability testing should be an integral part of stress testing.
Question 120- According To Who Guidelines What Is The Storage Condition Of Climatic Zone Iva And Zone I've?
Answer :
- Zone IV a: 30C and 65% RH (hot and humid countries)
- Zone IV b: 30C and 75% RH (hot and very humid countries
- Paramedic Interview Questions
Answer :
- Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Thailand
Pharmacology Interview Questions
Question 122- 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 the power of the analytical procedures used. The nature of stress testing will depend on the individual drug substance and the type of drug product involved.
Question 123- 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
Answer :
- Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection (WFI) has a recommend
Question 125- Brief About Ich Stability Guidelines?
Answer :
- Q1A- Stability testing of new drug substance & products
Question 126- What Is Significant Changes In Stability Testing?
Answer :
A 5% change in the assay for the initial value.
Question 127- If Leak Test Fail During In-Process Checks What Needs To Be Done?
Answer :
Immediately stop the 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 in-process.
- Collect random samples & do a retest.
- Blisters from the leak test passed containers shall allow going further and rest must be deblistered/defiled accordingly.
- Clinical Research Interview Questions
Question 128- How Many Tablets Shall Be Taken For Checking Friability?
Answer :
- For tablets with a unit mass equal or less than 650 mg, take a sample of whole tablets corresponding to 6.
Question 129- 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 fail 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.
Question 130- What Is The Standard Number Of Rotations Used For Friability Test?
Answer :
- 100 rotations
Medical Cardiology Interview Questions
Question 131- What Is The Fall Height Of The Tablets In The Friabilator During Friability Testing?
Answer :
- 6 inches. Tablets fall from 6 inches eight in each turn within the apparatus.
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Answer :
- To determine the need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time. If the tablet is too hard, it may not disintegrate in the required period. And if the tablet is too soft it will not withstand handling and subsequent processing such as coating, packing, etc.
Question 133- What Are The Factors Which Influence Tablet Hardness?
Answer :
- compression force
- Binder quantity(More binder more hardness)
- Moisture content
Question 134- Which Type Of Tablets Are Exempted From Disintegration Testing?
Answer :
Chewable Tablets
Question 135- Which Capsule Is Bigger In Size - Size '0' Or Size '1'?
Answer :
'0' size
Question 136- What Is The Recommended Temperature For Checking Dt Of A Dispersible Tablet?
Answer :
25 10C (IP) & 15 250C (BP)
Medical School Interview Questions
Question137- What Is Mesh Aperture Of Dt Apparatus?
Answer :
1.8 -2.2mm (#10)
Question 138- What Is The Pass/fail Criteria For Disintegration Test?
Answer :
- If one or two tablets/capsules fail to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is to meet if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.
Answer :
15 - 250C & 35 -55% RH
Pharmacist Interview Questions
Question 140- Which Method Is Employed For Checking uniformity Of Dosage Unit?
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Content uniformity
Question 141- 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 142- 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 deviate from the average weight by more than the percentage given in the pharmacopeia, and none can deviate more than twice that percentage.
- Weight Variation limits for Tablets.
Question 143- What Precautions Shall Be Taken While Collecting In Process Samples?
Answer :
- While collecting in-process samples, avoid contamination of the product being sampled (Don't collect samples with bare hands) & avoid contamination of sample taken.
Paramedic Interview Questions
Question144- 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 concerning service corridors.
Question 145- 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 lead to sticking.
- Sticking can occur because of too much binder or hygroscopic granular.
- Clinical Laboratory Technician Interview Questions
Question 146- What Checks Shall Be Carried Out, While Calibrating Dt Apparatus?
Answer :
While calibrating DT apparatus, following checks shall be performed.
Question 147- What Is In Process Checks?
Answer :
- In-process checks are checks performed during an activity, To monitor and, if necessary, to adjust the process to ensure that product conforms to its specification.
Question 148- What Is The Difference Between Disintegration And Dissolution?
Answer :
- Disintegration is a disaggregation process, in which an oral dosage form falls apart into smaller aggregates. (Disintegration time is the breakup time of a solid dosage form).
- Whereas dissolution is a process by which solid substance enters the solvent to yield a solution. It is controlled by the affinity between the solid substance and the solvent.
- In another word, disintegration is a subset of dissolution.
Question 149- Why Do We Calibrate A Qualified Equipment/instrument On Definite Intervals?
Answer :
- A piece of 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 in the accuracy of the data.
Question 150- 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.
Pharma Interview Questions and Answers:PART-1
Pharma Interview Questions and Answers:PART-2
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