Packaging and labelling operations
Article 42
1. Documented procedures shall be put in place to ensure that correct packaging materials and labels are used. 2. Appropriate measures shall be implemented to avoid mix ups of packaging materials or labels. There shall be physical or spatial separation from operations involving other intermediates or active substances. 3. Labels used on containers of intermediates or active substances shall indicate the name or identifying code, the batch number of the product, and storage conditions, when that information is critical to assure the quality of the active substance or intermediates thereof. 4. Whenever the intermediate or the active substance is intended to be transferred outside the control of the manufacturer, the label shall also include the name and address of the manufacturer, quantity of contents, special transport conditions and any special legal requirements. For intermediates or active substances with an expiry date, the expiry date shall be indicated on the label and on the certificate of analysis. For intermediates or active substances with a retest date, the retest date shall be indicated on the label and on the certificate of analysis. 5. Packaging and labelling premises shall be inspected immediately before use to ensure that all materials not needed for the next packaging operation have been removed. This inspection shall be documented in the batch production records, the facility log, or other documentation system. 6. Packaged and labelled intermediates or active substances shall be examined to ensure that containers and packages in the batch have the correct label. That examination shall be part of the packaging operation. Results of those examinations shall be recorded in the batch production or control records. 7. Intermediate or active substance containers that are transported outside of the manufacturer's control shall be sealed in a manner such that, if the seal is breached or missing, the recipient will be alerted to the possibility that the contents may have been altered.