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.
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
Tests for Tablet
- Weight variation
- Content uniformity
what are Defects of Tablet
- 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
Not more than 15 minutes.
Not more than 30 minutes.
Not more than 60 minutes.
What is the limit of friability
Not more than 1%
Defects of Coating
- Colour variation
- Orange peel effect
- logo filling
- 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
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.
- Assay or potency calculation of Active pharmaceutical Ingredient.
- How to become a skilled pharmacist?
- Classification of Excipients.
- Granulation process in pharmaceutical industries.
- How to calculate Double cone blender capacity.
- Types of Cleanrooms in pharmaceutical industries.
- Reasons and solutions for tablet capping.