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Cleaning Validation Glossary

Change Control

Management of changes to the cleaning process the ensure the process remains in a state of control

Defined in ICH Q7, Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients, as "A formal change control system should be established to evaluate all changes that could affect
the production and control of the intermediate or API". A change control is an all inclusive approach to implementing improvements or revisions to a system. All associated documentation must be reviewed by the quality units and implemented holistically. There is an expectation that after the change control has been implemented that there is an evaluation of the effectiveness of the change and evaluation of the first batch produced under the change.

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