Temperature mappings on warehouses, fridges, trucks, and others, is a must to ensure the good performance even in the worst condition.
To keep the temperature requirements all along the distribution chain of medicinal products is a must to guarantee its final quality and the patient safety.
Then the right temperature conditions must be guaranteed from the warehouse or the place where the product is stocked until the moment that is given to the final client, and therefore it can include several intermediate points, such as trucks, van, airlock, etc.
Qualification of transportation routes must be complemented with the temperature mappings on every intermediate point. Once the critical points are defined and the temperature sensors are placed, the measurement is held for 24 or 72 hours or during a week, depending on the equipment or facility´s requirements.
This procedure will allow us to identify the cold/hot points to place the product under consideration throughout every phase of its transportation chain.
Temperature mappings must be carried out in the ¨worst condition¨; highly recommended to carried out one in summer and another one in winter.
This is a very critical point considered by the inspection entities and certification bodies during audits, inspections or searches.
The guideline of November 2013 on Good Distribution Practices of medicinal products for human use, on its chapter 9.2 Transportation explains that:
¨It is the responsibility of the wholesale distributor 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.
Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers should be maintained and calibrated at regular intervals at least once a year.¨
On its 9.4-part marks:
¨For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature-controlled vehicles) should be used to ensure correct transport conditions are maintained between the manufacturer, wholesale distributor and customer.
If temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out and should take into account seasonal variations.¨
Qualipharma has a team of experts who master the temperature mappings procedures. We offer to our clients a customized solution according to their needs.