Change control
Article 14
1. The manufacturer shall evaluate the potential impact on the quality of the active substance of any changes to the manufacturing process that may affect the production and control of the active substance before implementing those changes. 2. Changes to the manufacturing process that negatively affect the quality of the active substance shall be not be implemented. 3. The manufacturer of an active substance shall notify without delay the manufacturers of medicinal products which he supplies with the active substance of any changes to the manufacturing process that may impact the quality of the active substance.