Pharmaceutical Questions and answer for interview

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What is Production?

All the activities involved in the manufacturing of a pharmaceutical product starting from receipt of raw materials to the completion of a finished product means, from Raw material Receipt to Finished product dispatch.

It contains the handling of manpower and recording of the manufacturing and the packing activity.

What is Batch Manufacturing Record(BMR)

BMR is a Document that provides a history of a batch mean how a product is manufactured step by step following written procedures.

It contains signs of qualified persons and operators involved in manufacturing.

What is Batch packaging Record (BPR)

Batch packaging record or  BPR is the document that provides a history of batch packaging and in-process checks of Packaging.

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Define Tablet

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

What is API

API stands for Active pharmaceutical ingredient.

API is a substance that gives pharmacological effects.

What is ExcipientInert materials which do not give any pharmacological effect.

Classification of Excipients for Solid Dosage form

  • Diluents
  • Binders
  • Disintegrants
  • Glidents
  • Lubricants
  • Colourants
  • Flavours

Tests for Tablet

  • Weight variation
  • Thickness
  • Hardness
  • Friability
  • Disintegration
  • Dissolution
  • Assay
  • Content uniformity

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Cleaning Validation In Pharmaceutical Industry

what are Defects of Tablet

  • Capping
  • Lamination
  • Sticking
  • Picking
  • Weight Variation

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.

What is Disintegration Time of Capsules
30 Min.

What is Disintegration Time of uncoated tablet

Not more than 15 minutes.

What is Disintegration Time of Film-coated tabs?

 

Not more than 30 minutes.

What is Disintegration Time sugar-coated tablets?

Not more than 60 minutes.

What is Disintegration Time of Enteric-coated table?
Tablets which have Enteric-coating should not disintegrate for 2 hours in acidic media and then these tablets when placed in basic media should disintegrate within 1 hour.
 

What is the limit of friability

Not more than 1%

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Defects of Coating

  • Sticking
  • Colour variation
  • Orange peel effect
  • logo filling
  • chipping
  • Film cracking

Types of coating

  1. Film Coating
  2. Enteric Coating
  3. Sugar Coating

 What is HVAC?

Heating Ventilation and Air conditioning

Functions Of HVAC

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

 Types of capsules

  • Hard Gelatin Capsule
  • Soft Gelatin Capsule
Revolution of Friability
 
25 rpm per minute and run-time is 4 minutes.
 
Name of 3 Natural binders
  • Starch 
  • Cellulose
  • Gelatin
Name OF Synthetic Binder

PVP k 30 or kollidon, povidone.

Why do we manufacture granules?

Granules are prepared for tablet compression because of the following main reasons.

  • To enhance flow because powders flow is poor.
  • To prevent weight variation.
  • To reduce dusty environment because powders are dustier.
  • To prevent segregation.
  • To improve content uniformity.
  • To improve compaction.
  • Powders are elastic so tend to cap but granules are plastic so prevent tablet capping.

What is a rat hole?

Rathole is a powder flow defect in which powder adheres to the walls of compression machine hopper or blender walls and stops the flow against walls creating a hole in the middle. It results in weight variation and fragile tablets during compression.

 
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30 thoughts on “Pharmaceutical Questions and answer for interview”

  3. GMP is a system to ensure products are consistently produced and controlled according to quality standards. The “c” in cGMP stands for current which indicates that the most recent standards, technology, and methods are being applied to operations.

  4. GMP is a system to ensure products are consistently produced and controlled according to quality standards. The “c” in cGMP stands for current which indicates that the most recent standards, technology, and methods are being applied to operations.

  21. validation is a whole process that assures the quality and durability and make the things up to date,
    while calibration is done for instrument to work properly.

  30. Asslamu alikum sir my question is what is the different between standars vessels and peak vessels

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