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When a Change of Information (COI) application or Revalidation application is submitted, data that changed (i.e., added, edited, or deleted) is flagged accordingly. A tag displays that identifies data as “Added”, “Edited” or “Deleted”. For further identification, a dark
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Q 2 (R1) Validation of Analytical Procedures: Text and ...
www.ema.europa.euFurthermore revalidation may be necessary in the following circumstances: • changes in the synthesis of the drug substance; • changes in the composition of the finished product; • changes in the analytical procedure; The degree of revalidation required depends on the nature of the changes. Certain other changes may require validation as well.