(2003; 148 pages)
4. Premises and facilities
4.1 Precautions must be taken to prevent unauthorized persons from entering storage areas.
4.2 Storage areas should be of sufficient capacity to allow the orderly storage of the various categories of materials and products, namely starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.
4.3 Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required on the label (e.g. temperature, relative humidity), these should be provided, checked, monitored and recorded. Materials and pharmaceutical products should be stored off the floor and suitably spaced to permit cleaning and inspection. Pallets should be kept in a good state of cleanliness and repair.
4.4 Storage areas should be clean, and free from accumulated waste and vermin. A written sanitation programme should be available indicating the frequency of cleaning and the methods to be used to clean the premises and storage areas. There should also be a written programme for pest control. The pest-control agents used should be safe, and there should be no risk of contamination of the materials and pharmaceutical products. There should be appropriate procedures for the clean up of any spillage to ensure complete removal of any risk of contamination.
4.5 Receiving and dispatch bays should protect materials and products from the weather. Reception areas should be designed and equipped to allow containers of incoming materials and pharmaceutical products to be cleaned, if necessary, before storage.
4.6 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 physical quarantine should provide equivalent security. For example, computerized systems can be used, provided that they are validated to demonstrate security of access.
4.7 There should normally be a separate sampling area for starting materials in a controlled environment. If sampling is performed in the storage area, it should be conducted in such a way as to prevent contamination or cross-contamination. Adequate cleaning procedures should be in place for the sampling areas.
4.8 Physical or other equivalent validated (e.g. electronic) segregation should be provided for the storage of rejected, expired, recalled or returned materials or products. The materials or products, and areas concerned should be appropriately identified.
4.9 Highly active and radioactive materials, narcotics and other hazardous, sensitive and/or dangerous materials and pharmaceutical products, as well as substances presenting special risks of abuse, fire or explosion, (e.g. combustible liquids and solids and pressurized gases) should be stored in a dedicated area that is subject to appropriate additional safety and security measures.
4.10 Materials and pharmaceutical products should be handled and distributed according to GMP as defined in this document.
4.11 Materials and pharmaceutical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination.
4.12 Materials and pharmaceutical products should be stored in conditions which assure that their quality is maintained, and stock should be appropriately rotated. The “first expired/first out” (FEFO) principle should be followed.
4.13 Rejected materials and pharmaceutical products should be identified and controlled under a quarantine system designed to prevent their use until a final decision is taken on their fate.
4.14 Narcotic drugs should be stored in compliance with international conventions, and national laws and regulations on narcotics.
4.15 Broken or damaged items should be withdrawn from usable stock and separated.
4.16 Storage areas should provide adequate lighting to enable all operations to be carried out accurately and safely.
4.17 Storage conditions for pharmaceutical products and materials should be in compliance with the labelling, which is based on the results of stability testing (see Appendix).
Monitoring of storage conditions
4.18 Recorded temperature monitoring data should be available for review. The equipment used for monitoring should be checked at suitable predetermined intervals and the results of such checks should be recorded and retained. All monitoring records should be kept for at least the shelf-life of the stored material or product plus 1 year, or as required by national legislation. Temperature mapping should show uniformity of the temperature across the storage facility. It is recommended that temperature monitors be located in areas that are most likely to show fluctuations.
4.19 Equipment used for monitoring should also be calibrated at defined intervals.