Handling of materials and products
Article 27
1. Handling of materials and products, including aspects related to the receipt, quarantine, sampling, storage, labelling and packaging, shall be done in accordance with written procedures or instructions and recorded as appropriate. 2. All incoming materials shall be checked to ensure that the consignment corresponds to the order. 3. Containers shall be cleaned where necessary. Damage to containers and any other problem (e.g. evidence of seal tampering or evidence of breaches of package integrity) that may adversely affect the quality of the material shall be investigated, recorded and reported to the department responsible for quality control. 4. Transport conditions for bulk products, intermediate products and samples shall be verified to ensure compliance with any specified conditions. 5. Incoming materials shall be physically or administratively quarantined immediately after receipt, until their release is authorised by a responsible person, after verification of compliance with the relevant specifications. If one material delivery is made up of different batches, each batch shall be considered separately for the purposes of sampling, testing and release. 6. All materials shall be stored under appropriate conditions to ensure the quality and in an orderly fashion to permit batch segregation (physical or electronic) and stock rotation. 7. Containers shall be labelled appropriately, including: (a) the designated name of the product and internal code reference, where applicable; (b) the batch number given at receipt; (c) where appropriate, the status of the content (e.g. in quarantine, on test, released, rejected); (d) where appropriate, an expiry date beyond which retesting is necessary. Where fully computerised storage systems are used, all the information referred to in points (a) to (d) does not need to appear in a legible form on the label. 8. At all times during the manufacturing process, all materials, bulk containers, major items of equipment and, where appropriate, rooms used shall be labelled or otherwise identified with an indication of the product or material being processed, its strength (where applicable), and batch number. Where applicable, this indication shall also mention the stage of production. 9. Special precautions shall be taken when handling dry materials or products to prevent the generation and dissemination of dust, particularly for highly active or sensitising materials.