[quote=KY Loke]Thank you for sharing.
I have 2 types of product (cream and liquid), and to cover 5 Filling-Packing Lines and with 3 repeats, it will be 30 Validation exercise.
I was trying to reduce the test plan. Any suggestion?
you are still confused with Process Validation of product and Qualification of Machines. You first go for all equipment/filling and packing machines qualification, perform capability studies and include that in performance qualification. After that you would be able to go for individual product process validation, that will be done typically with 3 commercial scale batches. for further clarification see WHO TRS 937 “Validation and Qualification” Annexure 4 Relationship between validation and qualiﬁcation;
Validation and qualiﬁcation are essentially components of the same concept.
The term qualiﬁ cation is normally used for equipment, utilities and systems,
and validation for processes. In this sense, qualiﬁ cation is part of validation."