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.
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 Excipient
Inert 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
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%
Defects of Coating
sticking
Colour variation
Orange peel effect
logo filling
chipping
Film cracking
Types of coating
Film Coating
Enteric Coating
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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