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Pharmaceutical Interview Questions answers for Freshers
Describe a tablet?
Answer: Tablet is a solid dosage form. The tablet contains active pharmaceuticalwith the excipients.
Define active pharmaceutical ingredients? Answer: Active Pharmaceutical Ingredient (API) is the primary and important ingredient in any drug formulation. It is a biologically active component liable for the drug effect.
What’s excipient and provides any two examples with their use?
Answer: Excipient is an inactive or inert component of the drug formulation which is useful for improving the tablet characteristics. Examples: Diluents, useful for increasing the majority volume of a tablet. Also used for improving the flow properties while compressing the tablet. Lubricants, useful for improving the flow properties while compressing the tablet.
Give examples for diluents and lubricants?
Answer: Diluent- Mannitol, sorbitol, starch, lactose, sucrose, etc. Lubricants – Magnesium stearate, calcium stearate, stearic acid, etc.
The method used for granules formulation?
Answer: Wet granulation, Dry granulation, Direct compression.
Tell about wet granulation, dry granulation, and direct compression method?
Answer: Wet granulation: It involves mixing, wet sieving, drying, dry screening, and compression. API and excipients are mixed well, then binder solution/ granulation fluid added to make a wet mass, wet mass is screening through an appropriate sieve, formed granules are dried. Dried granules are again screened through a sieve. It helps to interrupt down the granule agglomerates to supply a compatible size for preparing the tablet. These same size granules blended and compressed.
Dry granulation: It involves mixing, slug, screening, and compression. API and Excipients are mixed well and particles are aggregated under high for forming slugs. These slugs are screened to make uniform granules for the recompression of the tablets.
Direct compression: during this method, blend of API and Excipients are directly compressed to make tablets without changing the physical nature of the fabric itself.
Name three problems that come during compression?
Answer: Mottling, Capping, and lamination. Mottling- unequal color distribution of a tablet. Capping- Partial or complete separation of a table top or bottom crowns. Lamination– Separation of tablets into two or more layers.
What is the difference between picking and sticking?
Answer: Picking– due to adhesion to the punch faces, Localized portion missing on the surface of the tablet. Sticking- Adhesion of tablet localized portion to the punch faces leading to a rough and dull appearance.
Define capsule and the way many sorts of capsules are available?
Answer: capsules are solid dosage forms. It contains API and excipients enclosed during a water-soluble shell made from gelatin. Two types of capsules are available. Hard gelatin and soft Gelatin capsules.
Explain about hard gelatin capsules?
Answer: hard gelatin capsule contains two parts called body and cap. Body, a long narrow section. Cap, a smaller wide portion, fixes over the body.
Tell about the defects comes in Capsules:
Answer: Empty capsule, Cracked capsule, Dented, Telescopic, Unlocked capsule, Partially locked, improper polished, Printing defects, Caps depth variation, locking length, and Disintegration time problem.
Define parenteral?
Answer: Sterile dosage forms administered by injections through one more layer of the skin.
What is pyrogen?
Answer: They are the metabolic products of microorganisms produced from living or dead microorganisms.
Difference between water for injection (WFI) and sterile water for injection (SWFI)? Answer: WFI – Purified water without any pyrogen SWFI – Purified and sterile water with none pyrogen
Difference between ampule and vial?
Answer: Ampule is a straightforward dose unit and Vial is multiple-dose units.
Pharmaceutical Interview Questions for Executives and Higher Levels will update shortly:
SOME IMPORTANT QUESTIONS:
What types of problems you have faced during the production?
During the Audit, Which types of observations are found in your Department, and what action you took?
You have an urgent batch to dispatch and at the same time, you face a machine breakdown then what you will do?
What Are URS?
Answer: URS stands for User Requirements Specification, it tells what is the requirement of the users for the system. URS is written before within the validation process, the system is created later after this process. It is created by the End Users department, with the involvement of Quality Assurance. Performance Qualification is Tested with the requirements as described in URS. Specifications are not intended to be a technical document; readers with only a specification is required.
What Is 21 CFR Part 11?
Answer: 21 CFR part 11 related to the food and drug administration (FDA) Guidelines on electronic data records and signatures in the US. these come under Part 11, are considered to be trustworthy, reliable, and similar to paper records.
Pharmaceutical interview Quations related to Documentations:
What Is A Validation Plan?
Answer: Validation Plans are written before to proceed with the predefined goals and scope in validation projects. Validation Plans must include the validation process data and name with signature who are participating in validation projects. also include the timeline frame for completing the validation project.
Describe an Iq Document?
Answer: Installation Qualifications documents consist of a range of the tested cases to ensure the proper installation of the system within pharmaceuticals. for this design, specifications are used to properly install the system. Installation Qualifications is performed before completing Operational Qualification and Performance Qualification.
What Is An Oq Document?
Answer: Operational Qualifications documents consist of a range of the tested cases to ensure the proper functioning of a System. The operational qualification test requirements defined in the Functional Requirements. Operational qualification to be done before it comes in use.
What Is A Pq Document?
Answer: Performance Qualifications documents consist of a range of the tested cases to ensure that a System performs as per predefined criteria or operational qualification. before the system is being released these tests are sometimes conducted with power users.
Describe the Validation Summary Report?
Answer: Validation Summary Reports provide a depth view of the entire validation project. When regulatory auditors review validation projects, firest they typically start by reviewing the summary report. The validation summary report should include, A description of the validation project, All tests performed, and test results.
What Is A Change Request?
Answer: Change Control may be a general term describing the method of managing how changes are introduced into a controlled System. Invalidation, suggests how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain in check after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organizational capacity to control their systems.
Pharmaceutical interview Questions related to Stability studies:
Why we do Stress Testing In Stability Studies?
Answer: Stress testing helps in identifying the degradation of a particular product or a group of products, which can in turn help determine the path of the degradation and the intrinsic stability of the molecule. The nature of the study depends on which types of products and molecules are involved in testing.
Brief About Ich Stability Guidelines?
Answer: Q1 A- Stability testing of new drug substances & products.
What Are Significant Changes In Stability Testing?
Answer: A 5% change in an essay for the initial value.
Define the Climatic Zones For testing stability & storage condition for long terms?
Answer: ICH STABILITY ZONES: Type of Climate Zone I: Temperate zone II: Mediterranean/subtropical Zone III: Hot dry zone IV: (a) Hot humid/tropical zone IV (b) ASEAN testing conditions hot/higher humidity, Long term Storage condition Climatic Zone Temperature
Recommended Bio Burden Limits Of Purified Water & WFI?
Answer: the recommended bioburden limit for the purified water is 100 CFU/mL, and 10CFU/mL for the water for injection (WFI).
What is a dead leg?
Answer: dead leg where liquid can become stagnant in the piping system and not be exchanged during flushing.
Pharmaceutical interview Questions and answers related to QC will be updated shortly…
Important questions related to Packing departments:
What will you do if the leak test failed during the process?
Answer: Immediately stop the packing process and check for Sealing temperature Verify for any possible changes like foil width, knurling, etc. Check & quarantine the packed quantity of packed goods from in between the last satisfactory test and test failed. inform to Head and IPQA person, the IPQA person Collect random samples & do a retest. Blisters from the leak test passed containers shall allow going further and the rest must be deblistered/ defoiled accordingly.
Read all Pharmaceutical interview Questions/ answer Related to Packing….
Interview question from the compression stage:
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.
What is the formula for calculating the loss in weight during the friability test?
Ans: %Weight loss = Initial Weight – Final Weight X 100/ Initial Weight
How you determine Pass Or Fail Criteria For Friability Test?
Answer: Generally the test is run for once. lf any cracked, cleaved, or broken tablets present in the tablet sample after tumbling, the tablets fails the test. lf the results are doubtful, or weight loss is greater than the targeted value, repeat the test three times and calculate the means. A mean weight loss from the three samples is under limits, Then the result is satisfactory.
What Is The Fall Height Of The Tablets In The Friabilator During Friability Testing?
Answer: 6 inches, friability apparatus fall height is given as per predetermine criteria and RPM also set at 25 rounds per minute so RPM justifying that tablets fall only at height of 6 inches when we run at 25 RPM. Otherwise, tablets can fall at different angles so the result can be different.
Why Do We Check Hardness During Inprocess Checks?
Answer: at the start of the batch we have to need pressure adjustments on the tableting machine. Hardness can affect the disintegration time. if a tablet is too hard, it may not disintegrate in the required period of time. And if the tablet is too soft it will not withstand handling and subsequent processing such as problems during coating, packaging, and transportation.
Which Influence Tablet Hardness?
Answer: a compression force or Binder quantity (More binder more hardness) and Moisture content in granules.
Position Of Oblong Tablets To Be Placed In Hardness Tester To Determine The Hardness? Lengthwise / Widthwise?
Answer: The position of oblong tablets should be lengthwise because the probability of breakage is more in a long position as compare to widthwise.
Which Type Of Tablets Are Exempted From Disintegration Testing?
Answer: Chewable Tablets for eg. vitamines tablets
Which Capsule Is Bigger In Size – Size ‘0’ Or Size ‘1’?
Answer : ‘0’ size
What Is Mesh Aperture Of Dt Apparatus?
Answer : 1.8 -2.2mm (#10)
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.
Name of Method Is use For Checking “uniformity Of Dosage Unit”?
Answer: Content uniformity
Recommended Frequency of movement of Basket-rack Assembly In A DT Apparatus?
Answer: 28 – 32 cycles per minute.
How many tablets/capsules allow to deviate When Performing The ‘uniformity Of Weight’ Of The Dosage Unit?
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.
Why Positive pressure is recommended in the corridor area in pharmaceuticals?
Answer: Positive pressure is recommended in the corridor as compare to the process area to minimize or prevent cross-contamination of the products. meanwhile, a slightly negative pressure is kept in the process area.
What is the possible reason for sticking in tablets in the compression machine?
Answer: sticking may be due to less dry of granules. Too little or improper lubrication can also lead to sticking. Sticking can occur because of the additional high amount of binder and hygroscopic.
What Is In Process Checks?
Answer: In process checks are checks performed during an activity, ln order to monitor and, if necessary, to adjust the process to ensure that product conforms to its specification.
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 ‘break up’ time of a tablet/caplets). Whereas dissolution is a process by which a solid substance enters the solvent to yield a solution. lt is controlled by the affinity between the solid substance and the solver.
Important Pharmaceutical interview Questions related to equipment validation/calibration:
We do calibration of instruments or equipment at regular intervals why?
Answer: Sometimes it may possibly to “Drift” in instruments so To ensure the proper functioning of equipment we do the calibration. 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.
We do check three batches invalidation. Why not one or three?
Answer: because three batches are enough to identify trend analysis and provides adequate data for evaluation and reproducibility. First batch quality assumes to be accidental (co-incidental), Second batch quality assumes as regular (accidental), Third batch quality shows the validation(conformation).
Explain About the Revalidation Criteria Of Ahu System?
Answer: according to regulatory standard AHU shall be revalidated from time to time. AHU shall be revalidated in the following cases also: When the basic design of AHU is changed, When cleanroom volume is changed, When new equipment is installed When construction is carried out, that calls for revalidation.
What Needs To Be Checked During Ahu Validation?
Answer: During AHU validation, the following tests shall be carried out: Filter efficiency test, Air velocity & a number of air changes, Airflow pattern (visualization) Differential pressure, temperature, and RH Static condition qualification of area, Non-viable count conditions qualification.
What Is The Difference Between Calibration And Validation?
Answer: Calibration is a demonstration that, a particular Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. Whereas Validation is a documented program that provides a high degree of assurance that a specific.
Note: Visit regularly more Pharmaceutical interview Questions with answers to be upload soon
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