2. Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality.
3. The necessity of periodic checking of the validation results.
Related: Validation in Pharmaceutical Manufacturing
Note to point 3: Periodic revalidation must be done to ensure that no unintentional changes were made and to prove that the results of the previous validation procedures are still valid.
Also see: Purpose of Process Validation in Pharmaceuticals
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