Storage conditions and warehousing procedures
Article 43
Open ↗1. All materials used for the manufacturing of active substances shall be stored and handled under appropriate conditions (e.g. controlled temperature and humidity, where necessary) to ensure their quality and prevent degradation, contamination, and cross-contamination. 2. Whenever storage conditions are critical for the maintenance of material characteristics, records of those conditions shall be maintained. 3. Materials stored in fiber drums, bags or boxes shall be stored off the floor and, where appropriate, suitably spaced to permit cleaning and inspection. 4. Materials shall be stored for a period of time that has no adverse effect on their quality. Materials shall be controlled so that the oldest stock is used first. 5. Certain materials in suitable containers may be stored outdoors, provided identifying labels remain legible and containers are appropriately cleaned before opening and use. 6. Rejected materials shall be identified and controlled under a quarantine system designed to prevent their unauthorised use in manufacturing. 7. Separated areas shall be provided for the storage of quarantined, rejected, returned, or recalled materials.