Pharmaceutical Production Interview Questions and Answers

Here we mentioned a list of common interview questions and answers on pharmaceutical production (especially solid dosage form):

Q. What is pharmaceutical Tablet?

Pharmaceutical tablet is a solid dosage form prepared by a combination of API and Excipients by application of pressure.

Q. What is API?

API stands for Active pharmaceutical ingredient. Which gives pharmacological effects.

Q. What is Excipient?

Inert materials which do not give any pharmacological effect but need for desired dosage form and stability of the finished product.

Q. Why is Mg-stearate added in the last stage of blending before compression?

Mg-Stearate is added at the last stage of blending (before compression) due to prevent
the adversely effect on compressibility and dissolution characteristics.

Q. What type of measurement should be taken for hygroscopic material?

Relative humidity should be under control (<45%).
Wet granulation should be omitted.

Q. What are the common types of granulation?

Dry Granulation (Roller compaction)
Wet granulation (High shear mixing)
Spray dried granulation (Fluid bed granulation)

Q. Which parameter should be checked after granulation?

Assay
Blend uniformity
Particle size, flowability etc.

Q. What are the IPC tests of Tablet?

Weight variation
Thickness
Hardness
Friability
Disintegration time

Q. What are the Chemical tests of Tablet?

Dissolution
Assay
Content uniformity
Impurities
Water content

Q. What are the 5 common Defects of Tablet?

Weight Variation
Capping
Lamination
Sticking
Picking

Q. How can overcome the low hardness problem of a Tablet?

Increasing binder amount, changing diluent, increasing compression force type etc.

Q. What is Disintegration?

The time needed for tablet or capsule to break down into particles which pass through #10 mesh and no solid mass is left.

Q. What is Disintegration Time of Capsules, Uncoated tablet, Film-coated tablets and Sugar-coated tablets?

Capsule – Not more than 30 minutes
Uncoated Tablet – Not more than 15 minutes
Coated Tablet – Not more than 30 minutes
Sugar Coated Tablet – Not more than 60 minutes

Q. What is the limit of friability?

Not more than 1%

Q. How may Revolutions are required for Friability test?

100 revolutions (25 rpm per minute and run-time is 4 minutes).

Q. What are the types of coating?

Film coating
Sugar coating
Enteric coating

Q. What are the common defects of coating?

Sticking
Color variation
Orange peel effect
Logo filling
Chipping

Q. What are the commonly used opacifiers in tablet coating?

Titanium dioxide, Aluminum hydroxide, Aluminum silicate.

Q. Why Plasticizer used in coating solution?

To increase the plasticity and flexibility.
To reduce the glass transition temperature (Tg) facilitating transition.

Q. What are the commonly used plasticizers in coating solution?

Castor oil, Glycerin, PEG 1000, PEG 1450, PEG 3350.

Q. Which excipients are used in Enteric coating system?

CAP, PVAP, Kollicoat, Eudragit etc.

Q. What are the IPC parameters during Tablet coating?

Appearance
Inlet temperature
Outlet temperature
Pan RPM
Gun to bed distance
Spray rate
Weight gain
Weight variation
Thickness

Q. What is HVAC system?

HVAC stands for Heating, Ventilation and Air conditioning system.

Functions of HVAC:

Prevent cross-contamination.
Maintain Temperature
Maintain Humidity
Create Differential Pressure
Maintain Air Changes

Q. What are the types of capsules?

Hard Gelatin Capsule
Soft Gelatin Capsule

Q. What are the IPC parameters during Capsule Filling?

Appearance
Weight Variation
Net fill content of the powder
Locking length
Disintegration time

Q. Give an example of natural and synthetic binder?

Natural binder: Starch, Cellulose
Synthetic binder: Povidone, Kollidon

Q. What is a rat hole problem?

Rathole is a powder flow defect in which powder adheres to the walls of compression machine hopper and creating a hole in the middle. It results weight variation observed during compression.

Q. Why Methylparaben and Propylparaben used in combination?

They show synergistic effect with each other.

Q. What is Batch Manufacturing Record (BMR)?

Batch manufacturing record is a documentation that provides the history of a batch from the raw material dispensing stage to completion of the batch. Where includes Dispensing of raw material, Granulation process, Blending process, Compression process/Capsule Filling process, Coating process, Inspection and yield at different stages etc. It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.

Q. What is Batch Packaging Record (BPR)?

Batch packaging record is a documentation that provides the history of a batch from packaging material dispensing, blistering/striping , bottle packing, jar packing, dry syrup filling, labeling, carton packing, shipper packing etc. up to dispatch of a batch or Lot.

It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.

Q. What is Standard Operating Procedure (SOP)?

It is an authorized written document which describes the step by step instructions requirements for performing operations or any activity and it is non-specific to any product, process or material.

A standard operating procedure generally includes an introduction, background, ownership, instructions, and traceability, all outlined in an agreed-upon format and complete with references, appendixes, and annexures.

Q. What is the Basic Difference Between GMP and cGMP?

GMP stands for Good Manufacturing Practices, which require manufacturers to ensure that their products are safe, pure, and effective.
cGMP stands for Current Good Manufacturing Practices. Manufacturers who follow cGMPs must employ technologies and systems which are up to date that also comply with GMP regulations.

Q. What are the major responsibilities of a production planning executive?