Author: Álvaro Sánchez, Quality Assurance pharmacy technician at Logista Pharma.
Currently, the distribution of pharmaceutical products is regulated by a set of harmonised international standards known as Good Distribution Practices. These standards seek a common framework to guarantee the quality of medicines throughout the distribution chain, in order to achieve optimum safety and efficacy for patients. To this end, Logista Pharma employs the necessary tools to obtain an exact and extensive traceability, thus contributing to the maintenance of the necessary quality of all the products it stores and distributes.
One of the fundamental pillars for ensuring this quality, and the main basis of the regulations on Good Distribution Practices, is traceability. This consists of recording any movement related to a product, such as the date of receipt of the product at the distribution centre's facilities, the user who receives it and places it in its location, the person who prepares the order in which the article will be included or the dates of dispatch to distribution and delivery of the medicine.
To respond to this need, Logista Pharma has two software applications that control the necessary steps for storage, order preparation, handling, sample extraction, etc. of the batches of stored products.
Firstly, it has a Logistics Management System (LMS) that controls the stock. All the movements necessary for stock management are based in this system, with any movement involving the medicines stored and managed by Logista Pharma recorded here. It also has specialised state-of-the-art technology adapted to the needs of each company, which receives all the information from the LMS and stores it in the same way.
Both systems incorporate user control, meaning that every person with access to these software programs in which movement orders are placed has a user name and password assigned to them. Therefore, any movement involving medicines stored and dispatched from Logista Pharma is linked to the person who carries it out, as well as the date and time it takes place.
Now we are taking another step forward with the recently launched Serialisation process, which consists of assigning a unique identifier to each product unit. This allows us to go further in obtaining traceability at unit level, so today it is possible for us to know all the data related to the production and storage of a unit of serialised medicine, as well as the person who will prepare it to be sent in an order, the order reference in which it will be included, its destination and even the final patient to whom the medicine will be dispensed. This procedure is being carried out, among others, for the distribution of COVID-19 vaccines, providing exact information about the vaccination centre that receives each unit distributed.
The ultimate aim of traceability is patient safety, and it is critical and indispensable in batch recall processes, when a medicine has to be withdrawn from the market due to some type of defect. In such cases, we need to have exact information on all the points to which this product has been distributed.
In short, through constant innovation and the search for value-added solutions for clients, Logista Pharma is contributing to maintaining the quality of medicines.