If you want to join the pharmaceutical industry or want to learn about pharmaceutical manufacturing then after reading this article I’m sure that you will be able to learn all the important aspects of production.
Here you will learn all commonly asked pharmaceutical Interview questions which will be helpful for you to get a job or to prepare for a pharma production department interview.
In this article, you find the following questions related to,
- Production Pharmacist Interview Questions
- Production Manager Interview Questions
- Pharmaceutical Interview Questions
- Pharma Manufacturing Interview Questions
In this article, you will learn answers to more than 128 commonly asked interview questions of different departments in pharma.
Sterile Products Interview Questions
Let’s have a look over commonly asked interview questions related to sterile products.
What Are Parenteral Products?
Parenteral products, also known as injectables are sterile preparations of a drug in an aqueous or oily vehicle that are intended to be added directly into the bloodstream or to the muscle.
Which Properties are Required by a Good Parenteral Product?
A good Parenteral product must have the following properties,
- It must be free from microorganisms.
- It must be free from particulate matter like fibers, hair & particles.
- It must be free from pyrogens.
- It must be isotonic to body fluids.
- It must be free from chemical contamination.
- In the case of multiple doses, it must contain preservatives.
Which Are the Common Components of Parenteral Formulation?
Following are classes of excipients commonly used for parenteral product preparation,
- Solubilizing Agents
- Isotonic Agents
- Wetting agents
- Suspending Agents
- Emulsifying Agents
Examples Of Antimicrobials Used For Parenteral Products?
Commonly used preservatives for parenteral products are given below,
- Benzalkonium Chloride
- Phenylmercuric Nitrate
Examples Of Isotonic Agents Used For Parenteral Products?
Commonly used isotonic agents are given below,
- Sodium chloride
Examples Of Wetting Agents Used For Parenteral Products?
Commonly used Wetting Agents are given below,
- Tween 80
- Sorbitan Trioleate
Examples Of Suspending Agents Used For Parenteral Products?
Commonly used suspending Agents are given below,
- Methyl Cellulose
- Carboxymethyl cellulose
Examples Of Emulsifying Agents Used For Parenteral Products?
Commonly used emulsifying agents are given below,
Which Steps Are Involved In Manufacturing Of Parenteral?
- Preparation Of Solution
- Optical Checking
What Is Optical Checking?
The activity that is performed to check particulate matter in ampules against white & black backgrounds is known as the optical checking of ampoules.
What Is Sterility?
The term which is used to define the absence of microorganisms is called sterility.
What Is a Sterile Product?
A pharmaceutical dosage form that is free of microorganisms & manufactured under a controlled environment is known as a sterile product.
What Is a Cleanroom?
A clean room is an area which has a controlled number of living & nonliving particles.
Classification Of Clean Rooms?
According to ISO clean rooms in pharma are classified as follows
- ISO Class 5
- ISO Class 6
- ISO Class 7
- ISO Class 8
Read Complete Article
Which Cleanroom Is Used For Filling & Sealing Of ampoules?
Filling and sealing Of ampoules takes place in an ISO class 5 clean room.
What Is LFWB?
LFWB is a laminar flow workbench that is used for sterile product operations by maintaining an aseptic environment inside vertical or horizontal LFWB.
Types Of LFWB?
There are two types of LFWB one is a horizontal laminar flow hood & other is a vertical laminar flow hood.
- In horizontal laminar flow hoods, the air is along the surface of the workspace so there is no operator safety.
- In vertical laminar airflow, the airflow is from upside down on the workspace to ensure operator safety.
What Is the Frequency Of Particle Monitoring in sterile areas?
In grade A where critical activities like filling & sealing are performed continuous online monitoring is performed.
What Is Bioburden?
The total number of microorganisms related to a specific product before the sterilization process is known as bioburden.
What Is depyrogenation?
The process which is used to remove pyrogens is known as depyrogenation.
What Is HVAC?
HVAC is the Heating Ventilation & Air Conditioning system.
Components Of HVAC?
Following our main component of HVAC
- Coiling Coil
- Heating Coil
- Mixing Chamber
Functions of HVAC?
The following are the main functions of HVAC
- It is used to control temperature & humidity?
- It is used to create differential pressure.
- Prevent Cross Contamination.
What Is a HEPA Filter?
High-efficiency particulate Air Filters are known as HEPA.HEPA filters are classified as H13 & H14. It is used in Pharmaceutical cleanrooms to remove particles of 0.3 microns & larger. It has an efficiency of 99.97%.
Pore size Of HEPA?
HEPA filter has a 0.3 micron pore size.
What Is ULPA Filter?
ULPA is an ultra-low particulate Air Filter having a 0.12-micron pore size. It is classified as H15 & H16.
What Is ACPH?
ACPH is an abbreviation of air changes per hour. The number of air currents that pass through a clean room in one hour is known as air changes per hour.
Capsules Interview Questions
Let’s have a look over commonly asked interview questions related to capsules.
What Is a Capsule?
Capsules are unit solid dosage forms where drug substances are filled in a soft or hard shell usually made of gelatin.
Types Of Capsule Shells?
There are two types of capsules shell
- Hard gelatin capsules shell also known as HGC.
- Soft Gelatin Capsules Shell also known as SGC.
Types Of Gelatin?
There are two types of gelatin
- Gelatin type A
- Gelatin Type B
The type of gelatin which is obtained by acid-treated precursor is known Type A Gelatin & type B is from an alkali-treated precursor.
Which Method Are Used For Soft Gelatin Capsules Preparation?
Soft Gelatin Capsules are prepared by
- Plate Process
- Rotary Die process
Moisture Content Of Hard Gelatin Capsules?
- Usually 12 to 15 %.
- Below 10%,the shells become brittle & above 16% become soft resulting in filling problems.
Storage Condition For Empty Hard Gelatin Capsules?
Empty hard gelatin shells must be stored & handled at 30 to 45% relative humidity level.
What are Capsule sizes?
Largest Capsule Size Is?
Smallest Capsule Size Is?
Advantages Of Capsule?
- Easy to swallow
- It is an elegant Dosage Form
- The taste is masked due to the shell
Which Are Alternatives of Gelatin for the Shells Production?
- HPMC Capsules
- Starch Capsules
- Cross Linked Dextran
Liquid Dosage Form Interview Questions
Let’s have a look over commonly asked interview questions related to liquid products.
Excipients Used For Liquid Dosage Form?
- Viscosity Controller
What is Suspension?
A suspension is a heterogeneous system having two phases one is known continuous phase & other is the dispersed phase.
What Is a Continuous Phase in Suspension?
Continuous phase is also known as the external phase & it is composed of a liquid or semisolid.
What Is a Dispersed Phase in Suspension?
The dispersed Phase is also known as the internal phase & contains particulate matter which is insoluble but diapers in the continuous phase.
Classification Of Suspension?
- Oral suspension
- Topical Suspension
- Parenteral Suspension
Components Of Suspension?
- Wetting agents
- Flocculating Agent
- Deflocculating Agent/Dispersing agent
- Suspending Agents
- Protective Colloids
Tablets Interview Questions With Answers
What is a Tablet?
A unit solid dosage form manufactured by the process of compression containing active pharmaceutical ingredients & excipients is known as a tablet.
What Is Excipient?
Excipients are inert materials which have no pharmacological effect and are used to provide a specific property to the dosage form.
The materias in a dosage form other than active pharmaceutical ingredients known as excipients.
Classification of Excipients Used For Tablet Manufacturing?
Following are the main classes of excipients used for tablet manufacturing,
- Film former
What are Diluents?
Diluents Are the inert material used to make up the bulk volume.
Why Do We Use Diluents?
Diluents are used to make up the final volume meaning if you want to compress a tablet at a compression weight of 100 mg then suppose after adding API and all other excipients the weight reached 60 mg, the remaining 40 mg will be diluent to make up the final volume of 100 mg.
Give 4 Examples Of Diluents?
Following are 04 examples of Diluents,
What are fillers?
Diluents are also known as fillers.
What are bulking agents?
Diluents are also known as bulking agents because they are added to increase bulk weight.
Other names of Diluents?
Other names of diluents are as follow,
- Bulking agents
What Are Binders?
Binders are the excipients which are added to give bounding to the powders to form granules.
Example Of Binders?
Following are some examples of binders,
- Gum acacia
Classification of Binders?
Binders are classified into the following class,
- Natural Binders
- Synthetic Binders
- Semi-Synthetic Binders
Example Of Natural Binder?
Some Examples of natural binders
- Gum Acacia
Disadvantages of natural Binders?
The use of natural Binders is discouraged nowadays because natural binders promote microbial growth.
Example of Synthetic Binder?
Polyvinyl Pyrrolidone or PVP is the most commonly used synthetic binder.
Example of Semisynthetic Binders?
Commonly used Semi Synthetic binders are,
- Hydroxypropyl Cellulose
- Hydroxypropyl Methyl Cellulose
- Ethyl Cellulose
Effect of Binder on Disintegration?
Binder has a reverse effect on disintegration meaning if the concentration of binder is increased the disintegration time is prolonged.
Effect of Binder On Dissolution?
By increasing the amount of the binder the concentration of drug release is decreased so binders have a reverse effect on dissolution e.g by increasing the amount of binder, the drug release is slowed down & dissolution is retarded.
Effect of Binder On Tablet Capping?
The tablet capping issue may be resolved by increasing the amount of binder in the formulation because more binder gives strength to tablet edges.
What are Disintegrants?
The excipients which are used in formulation to break down the tablet into small fragments are known as
Example of Disintegrants?
Commonly used disintegrants are given below,
What are Super Disintegrants?
Super disintegrants are modified types of disintegrants which give rapid disintegration at low concentrations.
Examples of super Disintegrants?
- Sodium Starch Glycolate
- Croscarmellose Sodium
What is double Disintegration?
For better disintegration & dissolution profile the specific ratio of disintegrants is used intragranular & remaining is used in final blending this effect is known as double Disintegration.
What are Lubricants?
The excipients which are used to reduce friction between product & machine parts are known as lubricants.
Example of lubricant?
What Is Recommended Blending Time For lubricant?
The optimum blending time of powders or granules with lubricants is 3 to 5 minutes.
What Is The Effect of Lubricant on Disintegration?
The higher concentration of lubricant or higher blending time with hydrophobic lubricants may prolong the disintegration time.
Effect of Lubricant on Dissolution?
The higher concentration of lubricant or higher blending time with hydrophobic lubricants results in a low dissolution profile.
Effect of lubricant on tablet Capping?
A higher concentration of lubricant or high blending time with lubricants may result in an increased tendency of tablet capping.
What are Glidants?
The materials which are used to promote flow by reducing inter-particle friction are known as Glidants.
Example of Glidants?
The most commonly used Glidants are,
What is another name for Aerosil?
Aerosil is a brand name & it contains colloidal silicon dioxide also known as fumed silica.
Which is the Lightest excipient in pharma?
Fumed silica or Aerosil
Difference between lubricants & Glidants?
The class of excipients which is used to reduce friction between product & machine parts to prevent sticking & picking is known as lubricant.
The class of excipients which is used to promote flow by reducing inter-particle friction is known as Glidants.
Types of Granulation?
In Pharmaceutical industries, two types of Granulation are used for tablet manufacturing,
- Wet Granulation
- Dry Granulation
Types of tablet manufacturing Methods?
Three methods are used for tablet manufacturing,
- Wet Granulation
- Dry Granulation
- Direct Compression
Equipment Used For Wet Granulation?
The following are the most commonly used equipment for wet granulation,
- High Shear/low shear granulator
- FBD/Tray Dryer
- Oscillating Granulator/Co Mill
- Double Cone Blender/Bin Blender
Equipment Used For Dry Granulation?
Equipment used for dry granulation are
- Compression Machine /Roller Compactor
- Oscillating Granulator/Co Mill
- Bin blender/Double Cone Blender
Equipment Used For Direct Compression?
Equipment used for direct compression is
Which Equipment are Used For Drying The Granules?
In pharmaceutical industries following dryers are used for drying purposes during wet Granulation
- Tray Dryer
- Fluid Bed Dryer
Name of Blenders For Mixing?
Commonly used blenders during tablet manufacturing are,
- Bin Blender
- Double Cone Blender
- V shape Blender
- Sigma blade blender
Types of Granulators?
- High Shear Mixing Granulator
- Low Shear Mixing Granulator
Tell me About FBD.
FBD is a fluid bed dryer which is used in Pharma for drying granules manufactured by the wet granulation method.
The wet mass is loaded into the product trolley which is sealed below the drying chamber.
Inlet hot air is used for fluidization which also removes moisture from the product.
The air after fluidization passes through the filter which only allows air to pass & retain the product inside the product trolley.This process is continued till the product is dried.
Tell Me About Wet & Dry Granulation.
Wet granulation & dry granulation are types of granulation process which are used in pharma to manufacture tablets.
We granulation & dry granulation are commonly used in tablet manufacturing.
The wet granulation method is applied where our product is not degraded by moisture or heat & dry granulation method is used where our product is sensitive to moisture and heat.
How To Check End Point In Wet Granulation.
The endpoint is observed during the kneading stage of wet granulation & it is a very critical stage because in this stage the granule formation is observed to stop or continue the kneading process.
Enlist Granulation Defects
- Over Drying
- Under Drying
- Assay Issue
What Is Tablet Compression?
The process where powders or granules are converted into tablets by application of pressure using specific tooling.
Stages of Tablet Compression?
The tablet compression cycle is completed in four stages,
Parts Of A Compression machine?
The name of the most important compression machine parts are given below
- Upper Punches
- Lower Punches
- Pre Compression Rollers
- Main Compression Rollers
- Tail over Die
- Discharging Chute
- Lubrication Pump
4 Defects of Compression?
Commonly observed four compression defects are
Sticking Vs picking?
The tablet compression defect where the product is adhered to the side walls of the die & picking is the defect where a product is taken up by the punch tip having embossing.
Capping Vs lamination?
The removal of the crown edges of a core tablet is known as Capping.
The separation of the tablet into 2 layers is known as lamination.
How To Calculate Compression Machine Capacity?
To calculate the capacity of a compression machine, the following formula is used.
- Number of punches × rpm × Feeding system number × 60
What is the difference Between Upper & Lower Punch?
The neck of the upper punch is short & the neck of the lower punch is long.
How to Measure The Capacity of a Compression Machine hopper?
The capacity of the compression machine hopper is measured in liters not in kilograms because we can easily find out the amount of powder or granules to be added to the hopper by utilizing the bulk density with the help of the following formula
The volume of the hopper (Liters) × Bulk density of the product
What Is Tablet Coating?
The process in which a thin layer of polymer is applied over a rotating bed of tablets by spraying the suspension where the solvent is evaporated by the heat & solid content is deposited over tablets with time.
Purpose Of Tablet Coating?
Tablet coating may be done due to many reasons & some are given below,
- To mask the unpleasant taste.
- To protect from environmental factors like temperature & humidity.
- To give an appealing look.
- To prevent mix-ups.
- To alter the release pattern of drugs.
Types Of Tablet Coating?
Following are the main types of tablet coating performed in pharmaceutical industries,
- Film Coating
- Sugar Coating
- Enteric Coating
- Drug Coating
Classification of Tablet Coating?
We generally classify tablet coating into two classes,
- Functional Coating
- Non Functional Coating
What Is Functional Coating?
The type of coating in which polymer alters the release of active pharmaceutical ingredients is known as a functional coating.
An example is enteric coating.
What is Non-Functional Coating?
The type of coating in which polymer does not affect the release pattern of API is known as non-functional coating.
An example is a film coating
Types Of Coating On the Bases Of Solvent?
There are three types based on the type of solvent used,
- Aqueous Coating
- Organic Coating
- Hydroalcoholic Coating
Components Of Tablet Coating Suspension?
A good tablet coating system usually consists of the following components,
- Film Former
What Is The Principle Of Tablet Coating?
The tablet coating suspension after Atomization is sprayed over a moving bed of hot tablets where heat evaporates the solvent & solid contents in the suspension begins to deposit over each tablet.
What Is Atomization?
The division of coating suspension into fine mist by the use of air pressure is known as Automation.
Enlist 5 tablet coating defects.
- Orange Peel
- Color Variations
Why Twinning Occur?
Oblong tablets are susceptible to Twinning defects due to increased spray rate, low pan speed & low inlet air temperature.
Suitable Needle Size Of Guns?
It depends on the make & model of coating guns but the suitable needle size is 0.8 mm.
Suitable Gun to Bed Distance?
It depends on the type of solvent used & speed of the peristaltic pump but usually 8 to 15 Inch is suitable.
What is Tablet Bed Temperature?
The temperature of the warm rotating tablets during the tablet coating process is known as tablet bed temperature.
Who Tablet Bed Temperature Is Measured?
In advance coaters, it is displayed on HMI by a heat sensing probe but in conventional coaters, it can be measured by IR guns
Blistering & Packaging Interview Questions.
What If Cold Foil?
For blister packaging the Aluminium foil which is used for pocket formation is known as cold formable foil.
How Pockets are Formed In Cold Formable Foil?
As the name indicates cold mean no heat is used & pockets in cold formable foil are formed by the application of pressure using Teflon punches.
What Is Lidding Foil?
The printed thin foil of aluminum which is printed with all the requirements of the product is known as Lidding Foil as it forms a lid over pockets to seal a blister.
What Is a Leakage Test?
A specific test used to test the sealing of blisters, glass bottles etc which is done with negative pressure is known as the leakage test.
What Is Use For Leakage Tests?
A color dye , usually methylene blue, is used for leaking test apparatus due to its color & antimicrobial properties.
How Many Types Of Packaging?
There are 3 types of packaging in the Pharmaceutical industry,
- Primary Packaging
- Secondary Packaging
- Tertiary Packaging
What Is Primary Packaging?
The type of packaging which comes in direct contact with a product is known as primary Packaging.
- Blister Packaging
- Glass Bottles
What Is Secondary Packaging?
The type of packaging which is not in direct contact with the product but it contains primary Packaging.
- Unit carton containing Blister
What Is Tertiary Packaging?
The type of packaging which contains multiple secondary packs is known as tertiary packaging.
- Learn Blister Packaging Machine.
- Types of Blisters|Cold & Thermo formable
- Glass packaging|Four types of glass containers
- Types of pharmaceutical packaging.