Retention periods
Article 24
1. Batch documentation shall be kept for one year after the expiry of the batch to which it relates or at least five years after certification of the batch by the qualified person, whichever is longer. 2. Critical documentation that supports information in the marketing authorisation shall be retained whilst the authorisation remains in force, including relevant raw data such as data related to validation or stability. It may be considered acceptable to retire certain documentation, such as raw data supporting validation reports or stability reports, where the data has been superseded by a full set of new data. Justification for this shall be documented and shall take into account the requirements for retention of batch documentation. In the case of process validation data, the accompanying raw data shall be retained for a period at least as long as the records for all batches whose release has been supported on the basis of that validation exercise. 3. For other types of documentation, the retention period shall depend on the business activity which the documentation supports.