Validation

 

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.

1st RA

 

DQ gives input to URS

 

2nd RA after supplier quotation including process description

 

3rd RA after Design Review

 

DQ Report

 

IQ Protocol

 

OQ Protocol

 

WCA Protocol incl. plan for DOE

PQ Protocol

 

FAT and SAT can be prepared for validation activities

 

Establish Change Control

 

IQ Report

 

OQ Report

 

DOE

 

WCA Report

 

PQ Reports

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