Records must be retained for at least two years under the regulations. Is it necessary for us to keep them for longer?

The statutory “at least two years” is a minimum requirement. In practice, however, many companies choose to retain key records for longer as a matter of prudence and risk management. For example, a widely accepted best practice for batch manufacturing and distribution records is to retain them until at least one year after the expiry date of the medicine. This means that if a quality issue or adverse reaction report is identified shortly before or after the medicine expires, you can still trace the complete manufacturing and distribution history for investigation. For some records relating to company operations, validation or critical equipment (such as validation reports, training records for key personnel and change control records), permanent retention is recommended, or at least retention for a substantial period after the relevant system or equipment has been decommissioned.