This article provide frequently asked pharma interview Questions and Answers for production department that you may encounter during pharma interview.
Season-01 : Q-1 to Q-50 about Pharma Interview Questions for production
Production is the core department in pharma industry and required profound technical knowledge and skills about their job responsibilities. The following are list of Pharma Interview Questions and Answers you should overview at the start of your pharmaceutical production job interview preparation.
What are the common tablet defects and their remedies during compression?
The most common tablet defects observed in compressed tablets during compression are;
- Weight variation
- Friability variation
- Low hardness or soft tablets
- High hardness
- Sticking and picking
- Capping tendency
- Lamination
- Chipping
- Mottling
- Double impressions
- Thickness variation
- Collar formation on the edges
- Black spots or Black particles
- Metal particles
- Broken tablets
What are the remedies of tablet defects during compression?
Following are remedies for the tablet defects observed in compressed tablets during compression:
- Weight variation: Improve the powder flow, Improve the PSD of blend, Slowdown compression machine speed (RPM), Increase the feeder speed (RPM), Change feeder type if required
- Friability variation: Improve the PSD of blend, minimize excessive fines from blend, optimized the drying process in FBD, Increase the compression force and hardness.
- Low hardness or soft tablets: Increase the compression force and hardness, minimize excessive fines from blend.
- High hardness: Decrease the compression force and hardness, increase the thickness.
- Sticking and picking: Punch polishing, Slowdown compression machine speed (RPM), increasing compression force, improve the drying process like case hardening.
- Capping tendency: Increase dwell time, minimize excessive fines from blend, Slowdown compression machine speed (RPM), replace the old tooling with new tooling, Increase pre-compression force, adjust punch penetration.
- Lamination: Decrease the compression force and hardness.
- Chipping: Punch polishing, improve the drying process.
- Mottling: optimized the shifting and mixing process.
- Double impressions: fixed the machine setting
- Thickness variation: optimize the thickness
- Collar formation on the edges: Inspect tooling
- Black spots or Black particles: Clean punch cap, reduce lubrication time, clean machine
- Metal particles: Reset machine setting, Inspect tooling
- Broken tablets: Reset machine setting like ejection cam, scraper
What is the batch manufacturing record BMR or Batch production and control record (BPCR) ?
BMR or BPCR is a documentation record for each unit operation and includes the complete information relating to the completion of each significant step in the Batch manufacturing process.
What is the Batch packaging record (BPR) ?
Batch packaging record (BPR) is a documentation record that contains the complete information about the packaging process of the batch and requirement of GMP documentation.
What is batch and lots in the pharmaceutical industry?
Batch is a defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous.
It may sometimes be necessary to divide a batch into a number of sub-batches called lots, which are later brought together to form a final homogeneous batch.
In general as per pharma industry practice, in the manufacturing of a Batch of tablets if granulation is to be carried out in small portions, then each portion is called ‘Lots’. After granulation, all the lots of dried granules are then mixed to get one batch which is then lubricated with lubricant materials and compressed into tablets.
Similarly, coating of tablets in one batch can be carried out in a number of Lots. After coating, all the Lots of coated tablets are mixed to get one batch.
What is batch and Batch number in the pharmaceutical industry?
Batch: A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. Batch size may be defined either by a fixed quantity or the amount produced in a fixed time interval.
Batch Number: A unique combination of numbers, letters, and/or symbols which identifies a batch (or lot) and from which the production and distribution history can be determined
What are the types of batches in the pharmaceutical industry?
- Commercial batches
- Validation batches
- Verification batches
- Trial or dummy batches
- Exhibit or submission or bio batches
- Scale up batches
What is the difference between theoretical yield, expected yield and actual yield?
Theoretical yield: The quantity that would be produced at any appropriate phase of production, based upon the quantity of material to be used, in the absence of any loss or error in actual production.
Expected yield: The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on Validation batches, pilot scale, or manufacturing data. This data helps to define BMR limits for actual yield at any given stage.
Actual yield : The quantity of material or the percentage of theoretical yield calculated after completion of any stage in manufacturing. Actual yield should be within the specification of BMR limit any out of specification in actual yield should be handled by deviation.
What are the machine parameters you should record during Tablet coating in BMR?
- Pan size (Inch)
- Nos. of spray gun (Nos.)
- Nozzle diameter (mm)
- Types of baffles
- Pan on time
- Pan off time
What are the process parameters you should record during Tablet coating in BMR?
- Pan Load (kg)
- Uncoated tablets weight (mg)
- Nozzle aperture (mm)
- Distance between gun to bed of tablets (cm)
- Inlet air temperature (ºC)
- Outlet air temperature or Exhaust air temperature (ºC)
- Tablet Bed Temperature (°C)
- Pan speed (RPM)
- Spray rate (g/min)
- Atomization air pressure (kg/cm2)
- Pattern air pressure (kg/cm2)
- Inlet air flow (CFM)
- RH (%)
- Dehumidification Temperature (ºC)
- Dew point
- No. of Cycles
- Coated tablets weight (mg)
- weight gain (%)
- LOD (%)
What are the process parameters you should record during Compression in BMR?
- Compression machine speed (RPM)
- Feeder Speed (RPM)
- Main-Compression Force (KN)
- Pre-Compression Force (KN)
- Average weight of 20 tablets (mg)
- In-process parameters like, Hardness (N), thickness (mm), DT (min), Diameter (mm), Friability (%), Weight Variation, Stress friability, breakability.
What are the factors which influence tablet hardness?
- Main-Compression Force (KN)
- Pre-Compression Force (KN)
- Compression machine speed (RPM)
- Type of Tooling (D or B tooling)
- Binder quantity during granulation (More binder more hardness)
- Moisture content in blend (LOD)
- PSD of blend
Which type of tablets are exempted from Disintegration testing?
Chewable Tablets and Extended release tablets
What is the recommended temperature for checking DT of a dispersible tablet?
As per IP: 25 ± 10 (ºC) and 15 – 25 ºC as per BP.
What is the mesh aperture of DT apparatus?
1.8 -2.2 mm (#10) (2.0 mm ± 0.2 mm)
What are the recommended storage conditions for empty hard gelatin capsules?
15 – 25 ºC and 35 -55 % RH
Which method is employed for checking “Uniformity of dosage unit”?
A) Content uniformity
B) Weight Variation Weight variation is applicable for following dosage forms;
Hard gelatin capsules, uncoated or film coated tablets, containing 25 mg or more of a drug substance comprising 25% or more by weight of dosage unit.
Why do we consider three consecutive batches for process validation? Why not two or four?
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(confirmation)
In 2 batches we cannot assure the reproducibility of data, 4 batches can be taken but the time and cost are involved.
What is the difference between GMP & cGMP?
GMP: GMP is the part of Quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical Production. Such risks are essentially of two types:
- Cross-contamination
- Mix-ups
cGMP: Current Good Manufacturing Practices. This means any procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.
What is the difference between Qualification and Validation?
Qualification is equipment / instrument oriented but validation is process oriented.
What are the types of different training programs?
- Induction training
- Job oriented SOP training
- cGMP training
- On-going training
- CAPA or market complaint PMT training
- Outdoor training
- Awareness training
What is contamination, cross-contamination and mix-up?
Contamination: In any product, presence of a substance other than product manufacturing formula is called contamination.
Cross-contamination: Contamination of one product to another is called cross contamination.
Mix-up : undesirable mixing of material, product/ batch, unintentionally or accidently is called Mix-up.
What is the limit of Temperature in the pharmaceutical processing area?
Temperature: NMT 25 ˚C
What is the limit of Relative Humidity in the pharmaceutical processing area?
Relative Humidity: NMT 60 %
What is the limit of differential pressure in the pharmaceutical processing area?
Differential pressure (DP) : NLT 10 Pascal
Why is blending validation required? What quality parameters of product are considered for validation and what parameters of equipment are to be considered during Validation?
Because of to provide sufficient documented evidence to assure that the blending operation of product is capable of repeatedly and reliably producing a homogeneous material to meet established specifications when operated under defined standard conditions.
The following Quality parameters are to be considered, but not limited:
- Loss on Drying / Water content
- Bulk density / tapped density
- Residual solvent
- Particle size distribution (PSD)
The following parameters are to be considered for the equipment during validation, but not limited:
- Blender capacity
- RPM of the blender
- Occupancy of the blender
- Number of individual batches to be taken for each blend
- Mixing time
What is the definition of critical process parameters?
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.
what are the different types of cleaning in pharmaceutical companies?
There are three types of cleanings in pharmaceutical industry
- Type A cleaning:
- Type A cleaning shall be done after Product to product change over, after PM, after major breakdown more than 24 hr, after campaign length completion, after dirty hold time exceeded, same product with higher strength to lower strength, same product with any color change in formula.
- In type A cleaning full change over is carried out, machine shall be dismantle and all change parts should be thoroughly cleaned and no any previous product should be present.
- Type B cleaning:
- Type B cleaning shall be done after Batch to Batch or Lot to Lot change over.
- During Type B cleaning previous batch/lot should be removed and any labels of previous batch/lots should not be present in area. processing area, Equipment and waste bin should be cleaned.
- Type C cleaning:
- Type C cleaning shall be carried out at the end of day or in case of no any activity planned.
- During Type C cleaning processing area, Equipment and waste bin should be cleaned.
What is OOS?
Out of Specification (OOS) results are those results, generated during testing that do not comply with the relevant specification or standards or with the defined acceptance criteria.
What is OOT?
“OOT” stands for Out Of Trend. It means any test results obtained for a particular batch that is markedly different from the results of the batches in a series obtained using the same validated method.
What is the difference between instrument & equipment ?
Instrument: A device that takes a physical measurement and displays a value or has no control or analytical functions. e.g.: Stop watch, timers & thermometer, Harness tester, DT test apparatus.
Equipment: A device or collection of components that perform a process to produce a Result. e.g.: Compression Machine, Auto coater, FBD, RMG
How many types of raw material and packing material used in pharma?
Raw materials are classified into two types:
- Active pharmaceutical ingredient (API)
- Excipients: Intra-granular excipients and extra-granular excipients, lubricant and coating material
Packing materials are classified into two types:
- Primary Packing material
- Secondary Packing material
what is tablet and types of tablet in pharmaceutical industry?
Definition of Tablets
A tablet (also known as a pill) can be defined as pharmaceutical oral solid dosage form (OSD) containing drug substances (active pharmaceutical ingredient) with suitable excipient and prepared either by compression methods or molding methods.
Types of tablets
There are various types of Tablets and abbreviations used in referring to them are as follows
- Compressed Tablets or uncoated tablets
- Film-Coated Tablets
- Enteric-Coated Tablets
- Multiple Compressed tablets like Double layered tablets
- Controlled Release tablets
- Dispersible Tablets
- Effervescent tablets
- Sugar-Coated Tablets
- Compressed Suppositories or inserts
- Buccal and Sublingual Tablets
- Vaginal tablets
- Lozenges
- Implants
why coating is required for tablets ?
The application of coating to Tablets, which is an additional step in the manufacturing process, increases the cost of the product, therefore, the decision to coat a tablet is usually based on one or more of the following objectives ;
- To mask the taste, odour of drug.
- To improve appearance of the tablets.
- To provide physical and chemical protection for the drug from atmospheric effects, temperature, humidity and light.
- Functional coating (Control release, enteric coat, sugar syrup coat).
- To protect the drug from the gastric environment of the stomach with an acid-resistant enteric coating.
- To incorporate another drug or formula adjuvant in the coating to avoid chemical in compatibilities or to provide sequential drug release
- To improve the Pharmaceutical elegance by use of special colours and contrasting printing, which improves the appearance of the product.
What are the tablet coating defects?
- Orange Peel (Roughness)
- Tablet core erosion or rough edges
- Tablet Twinning
- Peeling off
- Capping tendency
- Tablet Breakage
- Edge chipping
- Logo Bridging or Logo In-filling
- Film cracking
- Color variation or shade variation
Why nitrogen gas used in the manufacturing area at room temperature and why not other gas?
Because of nitrogen is chemically less reactive and does not react with other elements at ordinary temperature. It is due to strong bonding in its molecules.
What is deviation and types of deviation?
Deviation is departure from the approved instructions /established standards.
There are two types of deviation and given below:
- Controlled / planned deviation: Any deviation from documented procedure opted deliberately for temporary period to manage unavoidable situation or improving the performance of the operations, without affecting the quality & yield of drug substance and safety of the operations shall be termed as controlled / planned deviation.
- Uncontrolled / unplanned deviation: Any deviation occurred in unplanned or uncontrolled manner such as system failure or equipment breakdown or manual error shall be termed as uncontrolled / unplanned deviation.
Difference between moisture content and LOD ?
Water Content determined by the Karl fisher method and it consists of only i.e moisture content. The results do not contain other volatile matter except the water.
Loss on drying (LOD) is determined by heating the sample above its melting point in an oven and it includes all volatile matter including water content and solvent. Loss on Drying is an unspecific analytical technique removing not only water but all other volatile impurities like solvent from a sample. The degree of drying is dependent on Temperature, Drying time.
LOD or Moisture content of pharmaceutical products can include both bound (e.g. water of hydration ) and free water. In case there are additional traces of other volatile impurities present, like alcohol: LOD may be higher than water content. in other cases, LOD may be lower than water content, as bound crystal water may not be removed by heating.
% LOD = % water content – % Water molecule in API
What do you mean by Critical Quality Attributes in pharma?
A critical quality attributes is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
What do you mean by Non-conformity?
Non-conformity is non-fulfillment of a specified or implied requirement of the quality management system or of a quality work product.
What do you mean by reconciliation?
A comparison, making due allowance for normal variation, between the amount of product or material theoretically & actually produced/used.
What is the QMS?
It is the quality management system to direct and control an organization with regard to quality.
What is a Master validation Plan (VMP)?
A document providing information on the company’s validation work program. It should define details of and timescales for the validation work to be performed. Responsibilities relating to the plan should be stated.
Which Test for the Steel SS 316L/304 identification?
Molybdenum test
- Drop of the molybdenum reagent on the steel part
- Pass the current 9Ω approx.
- If the pink or reddish color develop for more the 15 sec – SS 316L
- If the pink color disappear with in 15 sec – SS 304
What are environmental factors in the pharmaceutical industry? and required Monitoring?
- Room Temperature – NMT 25 ˚C
- Relative humidity (%RH) – NMT 60 %
- Differential pressure (DP) – NLT 10 Pascal
- Light -some product required halogen light
- Air movement
- Microbial contamination
- Particulate contamination
What are the types of Pass boxes in pharma?
- Dynamic Pass Box :
- For Material transfer from unclassified area to classified area.
- This Pass box has a HEPA filter and UV Light.
- Validation test: Air Velocity, Filter Integrity, Particle count
- Frequency of Validation is every six month
- Static Pass Box: For Material transfer from classified area to classified area
What types of granulation methods are used in pharma ?
- Wet granulation method: In this granulation binder solution is used.
- Dry granulation: Granulation is achieved with the help of mechanical compaction or force.
- Fluid bed granulation : Top spray FBP is used
What is the DT time of Different Tablets ?
- Uncoated tablets : Not more than 15 min
- Coated tablets : Not more than 60 min
- Effervescent tablets : Not more than 05 min
- Soluble tablets : Not more than 03 min
- Dispersible tablets : Not more than 03 min
- Orodispersible tablets : Not more than 03 min
- Enteric coated tablets : in 0.1 M HCL for 2 hrs – No crack should observed and in phosphate buffer solution pH 6.8 with NMT 60 min
- Chewable tablets : Not applicable
What is area or line clearance ?
To ensure that there are no any product, material, labels, residues of previous product or any other unwanted material on the area or line.
Implications of Line clearance are:
- GMP Violation
- Mix-ups
- Contaminations
- Cross contaminations
- Product Failure
- Market complaints
Which are the sources of dust, dirt and microbes ?
Man, Material, Machine, Environment
Very good coolection
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By IPQA vishal ( jonny sins)