RE: RE: RE: Retention of Documents Contribution from Alex Karory written on 1/10/2012 at 23:26
Original contribution: RE: RE: Retention of Documents written by Edy on 1/9/2012 at 14:52)
yes : the same paragraph you mentioned :
4.12 For other types of documentation, the retention period will depend on the business activity which the documentation supports. Critical ocumentation, including raw data for example relating to validation or stability), which supports information in the Marketing Authorisation should be retained whilst the authorization remains in force. It may be considered acceptable to retire certain documentation (e.g. raw data supporting validation reports or stability reports) where the data has been superseded by a full set of new data. Justification for this should be documented and should take into account the requirements for retention of batch documentation; for example, in the case of process validation data, the accompanying raw data should 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.
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