The responsibility is with both the manufacturer and the sponsor. The manufacturer who carries out release for supply needs to ensure that the batch meets its Marketing Authorisation, and that an on- going stability monitoring program is conducted and data is available to support the expiry date. The sponsor is responsible for the Marketing Authorisation, ensures an on-going stability testing program is performed and has access to the stability results. In the contract manufacturing agreement, the responsibility for on-going stability may be contracted out to the manufacturer or other parties.
