Order of priority of validation:

Because of resource limitation, it is not always possible to validate an entire company’s product line at once. With the obvious exception that a company’s most profitable products should be given a higher priority, it is advisable to draw up a list of product categories that are to be validated.

The following order of importance/priority with respect to validation is suggested:-

A.    Sterile products and their processes – 

1.      Large volume parenterals (LVPs)

2.      Small volume parenterals (SVPs)

3.      Opthalmics, other sterile products and medical devices.

B.     Non-sterile products and their processes – 

1.      Low dose/high potency tablets and capsules.

2.      Drugs with stability problems.

3.      Other tablets and capsules

4.      Oral liquids, tropical and diagnostic aids.