Receipt of medicinal products
The purpose of the receiving function is to ensure that the arriving consignment is correct, that the medicinal products originate from approved suppliers and that they have not been visibly damaged during transport.
Medicinal products requiring special storage or security measures are prioritised and once appropriate checks have been conducted they are immediately transferred to appropriate storage facilities.
Batches of medicinal products intended for the EU and EEA countries are not transferred to saleable stock before assurance has been obtained in accordance with written procedures, that they are authorised for sale.
Batches coming from another Member State, prior to their transfer to saleable stock are carefully checked by appropriately trained personnel. They will check the control report referred to in Article 51(1) of Directive 2001/83/EC or another proof of release to the market in question based on an equivalent system.
Storage
Medicinal products are stored separately from other products likely to alter them and are protected from the harmful effects of light, temperature, moisture and other external factors, an appropriate security of stocks being ensured.
Pharmnet Plus warehouse is equipped with all the necessary systems to ensure the proper temperature/humidity and the integrity of the products, including systems for temperature controlled storage of the products, between 2-8° C.
Pharmnet Plus pays special attention to the products needing special storage conditions. Stocks are rotated according to the ‘first expiry, first out’ (FEFO) principle.
Medicinal products are handled and stored in such a manner as to prevent spillage, breakage, contamination and mix-ups.
Medicinal products that are nearing their expiry date/shelf life are withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation.
Supply
For all supplies, the documentation is enclosed and records are kept according to the existing laws.
Pharmnet Plus has the responsibility to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport.
The car fleet ensures picking, transport and delivery of the medicinal products on the entire Romanian territory and it is equipped for maintaining and monitoring humidity and temperature of the medicines according to the recommendations of the manufacturers (including cold transport 2-8°C).
The required storage conditions for medicinal products are maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging. If a deviation such as temperature excursion or product damage has occurred during transportation, this will be reported to the distributor and recipient of the affected medicinal products.
Pharmnet Plus is responsible to ensure that vehicles and equipment used to distribute, store or handle medicinal products are suitable for their use and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity.
Equipment used for temperature monitoring during transport within vehicles and/or containers are maintained and calibrated at regular intervals at least once a year.
Pharmnet Plus uses dedicated vehicles and equipment when handling medicinal products in order to ensure that the quality of the medicinal product will not be compromised.
Where the transportation route includes unloading and reloading or transit storage at a transportation hub, Pharmnet Plus pays particular attention to temperature monitoring, cleanliness and the security of any intermediate storage facilities.
Pharmnet Plus makes efforts to minimise the duration of temporary storage while awaiting the next stage of the transportation route.
Containers, packaging and labelling
Medicinal products are transported in containers that have no adverse effect on the quality of the products, and that offer adequate protection from external influences, including contamination.
Selection of a container and packaging is based on:
- the storage and transportation requirements of the medicinal products;
- the space required for the amount of medicines; the anticipated external temperature extremes;
- the anticipated external temperature extremes;
- the estimated maximum time for transportation including transit storage at customs;
- the qualification status of the packaging and the validation status of the shipping containers.
Pharmnet Plus makes sure that containers bear labels providing sufficient information on handling and storage requirements and precautions to ensure that the products are properly handled and secured at all times. The containers enable identification of their contents and of the source.
Products requiring special conditions
Regarding deliveries containing medicinal products requiring special conditions such as narcotics or psychotropic substances, Pharmnet Plus maintains a safe and secure supply chain for these products in accordance with requirements laid down by the Member States concerned. There are additional control systems in place for delivery of these products.
For temperature-sensitive products, (e.g. thermal packaging, temperature-controlled containers or temperature-controlled vehicles, etc.) Pharmnet Plus uses qualified equipment to ensure that correct transport conditions are maintained in the supply chain.
For the temperature-controlled vehicles used, the temperature monitoring equipment used during transport is maintained and calibrated at regular intervals. Temperature mapping under representative conditions is carried out taking into account seasonal variations.