CRED Managing Variations Effectively

Some Variations Can be Avoided

 Post-approval changes to a product often require the submission of a variation, but not always  Amount of detail put into Module 3 at time of MAA submission will determine the number of variations  Need to maintain a balance between: 1. The amount of data required for assessor review to ensure a product of consistent and appropriate quality is manufactured vs. 2. What is required to be maintained in the Company’s Quality Systems (e.g. GMP info)  It is in the interest of both the MAH & CA to avoid unnecessary variations