GDP at pharmacies - Q&A
Good distribution practice at pharmacies
Pharmacies play an important role in the movement of pharmaceuticals from the manufacturer to the consumer. Among their many responsibilities, pharmacies must make sure they fulfil the rules of good distribution practice (GDP), for example to ensure that the quality of medicines is not impaired during storage or transport.
The pharmacies must therefore act in accordance with the provisions of the executive order on distribution of medicinal products, which applies to pharmacies. In addition, the pharmacies must act in accordance with the guidelines on good distribution practice of medicinal products for human use, which in Denmark applies to both human and veterinary medicines.
Please find below our questions and answers on good distribution practice for pharmacies. The Q&A list is not exhaustive.
Question and answer
What requirements are there for temperature monitoring at pharmacies?
The pharmacy must ensure that the medicines are stored under the required storage conditions. As a result, the temperature must be continuously monitored, controlled and documented. This is most appropriately ensured using electronic equipment that logs the temperature at regular intervals.
Thermometers for manual reading can also be used if the applied procedure for thermometers for manual reading fulfils the requirements for monitoring, control and documentation to ensure the medicines are stored at the right temperature.
How is the qualification of equipment for temperature monitoring done?
Equipment that logs the temperature at regular intervals should be qualified in connection with installation and must be re-qualified in connection with repairs/changes.
The qualification of equipment for electronic temperature monitoring implies that the pharmacy must at least verify that:
the equipment fulfils the requirements set by the pharmacy
everything has been received and installed correctly
relevant functions work, including any alarm functions
the equipment has been calibrated
The qualification of electronic equipment for temperature monitoring should be documented.
If the system has been set up to give alarms when temperatures outside the defined interval are registered, a test must be done at least once a year to verify that the device does in fact give an alarm when the temperature differs from the defined interval.
Temperature deviation alarms must be tested on both the upper and lower temperature limits at room and refrigeration temperatures.
Can the pharmacy itself handle the qualification of equipment for temperature monitoring?
Yes – the qualification of equipment for temperature monitoring can be done by the pharmacy.
How often should the temperature be checked?
Pharmacy using thermometers for manual reading, must read the temperature at least once a day – and more often in refrigerators. The temperature should be noted with date, time and initials.
If the pharmacy uses non-qualified equipment for temperature monitoring, the temperature must also be read at least once a day – and more often in refrigerators. The check must be documented noting the temperature with date, time and initials.
If the pharmacy uses qualified electronic equipment for temperature monitoring that does not give active alarms, the temperature must be checked at least once a day – and more often in refrigerators. The check must be documented noting the temperature with date, time and initials to verify that the temperature has been checked.
If the pharmacy uses qualified electronic equipment that gives active alarms, the documented control described in the scenarios above can be ignored.
For how long should the documentation on temperature monitoring be kept?
The documentation on temperature monitoring should be kept for five years either in physical or electronic format.
How should temperature deviations be handled?
If the pharmacy notes deviations in the defined temperature interval, it should assess the consequences for the quality of the medicines that have been stored in areas affected by the temperature deviation. In addition, the pharmacy should urgently try to bring the temperature to the needed interval and ensure that until this happens no storage takes place of medicines whose quality would be impaired by the storage.
It must be described in a guideline how to handle temperature deviations, and the handling of specific temperature deviations must be documented.
How often should temperature loggers/thermometers be calibrated?
The pharmacy must keep documentation to prove that the equipment used for temperature measurement has been calibrated. The equipment should be calibrated at the temperature interval where it is to be used.
Equipment for temperature measurement must generally be calibrated once a yar.
Should the pharmacy carry out temperature mapping?
The purpose of temperature mapping is to identify critical spots in the room with the purpose of establishing where to place the measuring points to enable a representative temperature monitoring.
Temperature mapping should be carried out to reflect worst-case weather conditions.
The pharmacy must ensure that any rooms used for storage of medicines are temperature-mapped, regardless of whether it concerns existing rooms or refurbished rooms.
Temperature mapping must be documented.
Are pharmacies subject to pest managment requirements?
The pharmacy’s rooms must be designed and equipped to ensure protection against insects, rodents and other animals. The pharmacy must make a risk assessment based on which to establish a programme for preventive pest control.
Can medicines be placed directly on the floor?
Medicines may not be placed directly on the floor, unless the packaging is designed specifically for such storage. It should be possible to carry out effective cleaning. Medicines that are not stored on shelves and the like must therefore be readily movable, e.g. stored in boxes on wheels.
How should recalled, expired and falsified medicines be stored?
Medicines that are – or are presumed to be – falsified as well as expired or recalled medicines must immediately be separated physically from the medicines for sale and stored in an area separate from all other medicines (quarantine area). This area must be clearly demarcated, and it must be ensured that the medicines remain separated from the inventory for sale.
What requirements are there for the pharmacy's delivery of medicines?
The pharmacy's delivery of medicines must be planned on the basis of a risk assessment. It must be ensured that the medicines are in transit for the shortest possible period and that the approved storage conditions are complied with during the transport. The equipment used for temperature measurement during transport should be calibrated in the same way as other thermometers and thermo loggers.
What requirements are there for the pharmacy's consignment of medicines?
The pharmacy must ensure that the medicinal product is packed and dispatched in a way ensuring that the quality of the product is not impaired. If medicines require refrigerating, the pharmacy must ensure that during transport the medicinal product has been stored in accordance with the approved storage conditions.
The requirements appear from the executive order on pharmacies’ and retail distributors’ online sale and on consignment of medicinal products. The executive order applies irrespective of whether the product is sold online.
How often should the validity of the supplier's authorisations be checked?
When the pharmacy receives medicinal products, it must verify that the supplier in question holds a valid and relevant company authorisation for the handling of medicinal products. This must be verified at each delivery. If the pharmacy trades with the same supplier regularly, the authorisation can be verified periodically based on a risk assessment.
For how long should the documentation on good distribution practice be kept?
The pharmacy should keep any document on good distribution practice for a period of five years. For example, this includes documentation on the handling of recalls, temperature monitoring, etc. The documentation can be stored in an electronic or physical format.