Premises & Equipment

Requirements for suitable and adequate premises and equipment to ensure proper storage and distribution of veterinary medicinal products.

4.1 Premises

  1. Wholesale dealers must have suitable and adequate premises and equipment to ensure proper storage and distribution of veterinary medicinal products. In particular, the premises must be clean, dry and maintained within acceptable temperature limits.
  2. Where premises are not directly operated by the wholesale dealer, a contract must be in place. The contracted premises must hold its own WDA, separate to that held by the contract giver, and can only wholesale the products defined in that authorisation.
  3. The premises must be suitably secure, structurally sound, sufficiently lit and large enough to allow safe storage and handling of the veterinary medicinal products. Unauthorised access must be prevented by appropriate measures and visitors must be accompanied at all times. There must be appropriate procedures in place for site security, including visitor and contractor access.
  4. Premises and storage facilities must be clean and free from litter and dust. There must be appropriate cleaning programmes, instructions and records in place which also include procedures for handling spills and other contaminants. Appropriate cleaning equipment and cleaning agents must be chosen and used so as not to present a source of contamination.
  5. Vehicles must be cleaned regularly, according to the cleaning procedure, using appropriate equipment which will not constitute a source of contamination.
  6. Premises must be designed and equipped to afford protection against the entry of insects, rodents or other animals. A preventative pest control programme must be in place.
  7. Rest rooms, washing facilities and refreshment rooms for employees must be adequately separated from the storage areas. The presence of food, drink, smoking materials or veterinary medicinal products for personal use must be prohibited in the storage areas.
  8. Veterinary medicinal products must be stored in segregated areas that are clearly marked and have access restricted to authorised personnel, or a system replacing physical segregation can be used, such as electronic segregation based on a computerised system, but this must provide equivalent security and have been appropriately validated.
  9. The premises must be designed (or adapted) to allow veterinary medicinal products which require specific storage and handling to be stored in accordance with the instructions in the products’ summary of product characteristics (SPC), including any additional security or safety requirements, for example, controlled drugs, medical gases or flammable products.
  10. Segregated storage facilities must be in place and ensure physical segregation of these products from the saleable stock. This includes any expired, damaged, suspected counterfeit or recalled veterinary medicinal products, in addition to any non-defected returns which are awaiting assessment. The level of security must be appropriate for the products stored.
  11. Veterinary medicinal products which are imported for re-export, so not intended for the UK market, must also be physically segregated from other stock.
  12. Goods-in/receipt areas and dispatch/outloading bays must protect products from prevailing weather conditions. There must be adequate separation between the designated receipt/goods-in area, the storage area, and the dispatch area. Procedures must be in place to maintain control of incoming and outgoing goods.

4.2 Temperature and Environmental Control

  1. Suitable equipment and procedures must be in place to check the environment where veterinary medicinal products are stored. Environmental factors to be considered include temperature, light, humidity and cleanliness of the premises.
  2. An initial temperature mapping exercise must be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment must be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The documented mapping exercise must be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the storage facility or the temperature controlling equipment. For small storage areas of a few square meters that are at room temperature, a documented assessment of potential risks, such as heaters, must be conducted and temperature monitors must be placed accordingly.
  3. Temperature monitoring devices must be calibrated to an accuracy of no more +/-0.5°C, and that accuracy checked at least annually. Certificates of calibration must be retained on file.
  4. For cold chain veterinary medicinal products only refrigerators or coolers capable of maintaining these conditions must be used. There must be sufficient space for air to circulate in smaller refrigerators.
  5. Continuous temperature monitoring is required, and daily records kept. If the monitoring devices do not record the temperature continuously and automatically then daily maximum and minimum temperatures must be recorded for each device. Where there is limited data storage, devices must be checked daily and downloaded at least weekly.
  6. Larger refrigerators and walk-in cold rooms may need more than one thermometer if there is not a built-in system to monitor all areas. Temperature alarms must be fitted to refrigerators where the product is at risk of freezing.

4.3 Equipment

  1. All equipment that has an impact on storage and distribution of veterinary medicinal products must be designed, located and maintained to a standard which suits its intended purpose. Planned maintenance must be in place for key equipment vital to the functionality of the operation.
  2. Calibration of equipment must be traceable to a national or international measurement standard. Where appropriate, alarm systems must be in place to provide alerts when there are excursions from pre-defined storage conditions. Alarm levels must be appropriately set, and alarms must be regularly tested to ensure adequate functionality.
  3. Planned maintenance must be in place for key equipment and any repairs, maintenance work and calibration operations must be carried out in such a way that the integrity of the veterinary medicinal products is not compromised.
  4. Records must be kept of any repairs, maintenance and calibration activities.

4.4 Computerised systems

  1. Before a computerised system is brought into use, it must be demonstrated that it can achieve the required results accurately and consistently and can both store the data for at least 5 years and be accessible for inspection.
  2. Data must be secured by physical or electronic means and protected against accidental or unauthorised modifications. Data must be protected by backing up at regular intervals.
  3. Procedures to be followed if the system fails or breaks down must be defined. This must include systems for the restoration of data.
  4. Data must only be accessed, entered or amended into the computerised system by persons authorised to do so.