During installation qualification, equipment maintenance and calibration schedules and procedures should be established. Equipment should be calibrated before and after process validation to determine whether the equipment remained in calibration during the entire process validation study. If the equipment is found to be out of calibration at the end of the study, the validity of the results is called into question. Installation qualification does not have to be performed again if it was recently done for a previous validation. When equipment is moved, a new installation qualification should be performed.
Installation qualification is essential for successful process validation.
The process must be developed before it can be validated. From time to time we see manufacturers who try to validate processes before they have completely developed them and established process parameters. It is important to remember that validation is dynamic and specifications and parameters may be changed as a result of the validation efforts. These changes would need to be validated. Finally, the product should be qualified.