The validation is based on requirements and risk analazis with focus on end user risks.
Low risks should be handled outside validation in normal quality control system.
In some cases, the output can checked using expanded inspection and then do a retrospective PQ later. It is very important to include the production site in validation activities, as they have to maintain the validation onwards.
To reduce the PQ activities, the final products should be divided into groups.
DQ gives input to URS
2nd RA after supplier quotation including process description
3rd RA after Design Review
WCA Protocol incl. plan for DOE
FAT and SAT can be prepared for validation activities
Establish Change Control