Classification of Defects in Tablets and Capsules

Tablets and Capsules are classified in to three categories i.e Critical Defects, Major Defects and Minor Defects.

What is Critical Defects :

The defects which causes failure in the Drug Product and such type of defects that is likely to result in hazardous or unsafe conditions for an individual in using the product and that does not meet the mandatory regulations. These defects put businesses of a organization at serious risk which includes product liability issues, lawsuits and product recalls.

What is Major Defects :

The defects that likely to reduce the usability and functionality of the Drug Products. Major defects are those which could adversely affect the function, performance or appearance of a product.

What is Minor Defects :

Such defects does not affect the use of the product for its indicated purpose but divert from the appearance of the product, cosmetic in nature. In most cases, the customer wouldn’t even notice a minor defect on a product and the customer wouldn’t likely return an item due to a minor defect alone.

Critical Defects :

Major Defects :

Minor Defects :


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