(2003; 148 pages)
12.15 Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products with proper separation and segregation: starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.
12.16 Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean, dry, sufficiently lit and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, controlled, monitored and recorded where appropriate.
12.17 Receiving and dispatch bays should be separated and protect materials and products from the weather. Receiving areas should be designed and equipped to allow containers of incoming materials to be cleaned if necessary before storage.
12.18 Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel. Any system replacing the physical quarantine should give equivalent security.
12.19 Segregation should be provided for the storage of rejected, recalled, or returned materials or products.
12.20 Highly active and radioactive materials, narcotics, other dangerous drugs, and substances presenting special risks of abuse, fire or explosion should be stored in safe and secure areas.
12.21 Printed packaging materials are considered critical to the conformity of the pharmaceutical product to its labelling and special attention should be paid to sampling and the safe and secure storage of these materials.
12.22 There should normally be a separate sampling area for starting materials. (If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination.)