Production and in-process control
Article 9
1. Production operations shall be subject to controls in order to monitor and adjust the production process or verify that the active substance conforms to the specifications of quality and purity pursuant to Article 12(1). Production operations which are critical to ensure that the active substance meets the quality specifications referred to in Article 12(1) shall be carried out under the visual supervision of qualified personnel or subjected to an equivalent control. 2. Weighing and measuring of raw materials and active substance starting materials shall be accurate and shall be conducted in a manner which does not affect their suitability for use. 3. Production operations, including any operation after purification of the active substance intermediates or the active substance, shall be conducted in a manner that prevents raw materials, active substance starting materials, active substance intermediates and active substances from being contaminated by other materials.