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.
