Production operations
Article 34
1. Raw materials for manufacture of active substances or intermediates thereof shall be weighed or measured under appropriate conditions that do not affect their suitability for use. 2. Balances and measuring equipment shall be of an appropriate range and precision to ensure the accuracy of weighing operations. 3. Whenever a material is subdivided for later use in production operations, the container receiving the material shall be suitable and shall be identified so that the following information is available: (a) material name or item code; (b) receiving or control number; (c) weight or measure of material in the new container; (d) re-evaluation or retest date if appropriate. 4. Critical activities, including the critical weighing, measuring, or subdividing operations shall be verified or subjected to an equivalent control. Prior to use, the manufacturer shall ensure that its production personnel verifies that the materials are those specified in the batch record for the intended active substance or intermediate thereof. 5. Actual yields shall be compared with expected yields at designated steps in the production process. Expected yields with appropriate ranges shall be established based on previous laboratory, pilot scale or manufacturing data. Deviations in yield associated with critical process steps shall be investigated to determine their impact or potential impact on the resulting quality of the affected batches. 6. Any deviation in yield shall be documented and explained. Any critical deviation shall be investigated. 7. The processing status of major units of equipment shall be indicated either on the individual units of equipment or by appropriate documentation, computer control systems, or alternative means. 8. Materials to be reprocessed or reworked shall be appropriately controlled to prevent unauthorised use.