Change Control

Changes made to cleaning SOPs, analytical methods, detergents, equipment, product formulation, etc. should fall under the auspices of the change control policy of the company. Formal documentation will be required to make changes to these items. Changes performed under the change control policy will require reconfirmation of the original cleaning validation results. In case the change is deemed to be fundamental to the grouping philosophy or to the cleaning method, the change may require a revalidation, which may differ from verification only by the amount of sampling.

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