Contract manufacturing
Article 17
1. A manufacturing operation or an operation linked thereto which is to be carried out on behalf of the manufacturer of the active substance by another party (‘the contract manufacturer’) shall be the subject of a written contract. The contract shall clearly define the responsibilities of the contract manufacturer with regards to good manufacturing practice. 2. The manufacturer of the active substance shall control that operations carried out by a contract manufacturer comply with good manufacturing practice. 3. A manufacturing operation or an operation linked thereto which has been entrusted to a contract manufacturer shall not be subcontracted to a third party without the written consent of the manufacturer of the active substance.