Process Validation Policy

in this post Process Validation Policy is describe in pharmaceuticals industry.

Purpose:  

Purpose of this document is to describe the company wise policy for the selection and conduction of 

Process Validation.

Scope:

This policy is applicable for the selection and conduction of products manufactured in Production for 

process validation.

Detail: 

1. Currently manufacturing products not subjected to initial validation are subjected to concurrent process validation.

2. Consistent manufacturing products with satisfactory history in manufacturing will be selected for

3. Retrospective Process Validation study.

4. Products having different strengths will be selected on the basis of criteria mentioned in the table given  below.

5. Process Validation should be conducted after the completion of pre-requisite for process validation (e.g. Analytical Method Validation, Equipment Qualification, satisfactory processing & yield etc.)