Medication control - ISS (EN)
Medicines, vaccines and advanced therapies
Drugs that have been developed are subjected to a series of checks to ensure that their quality is maintained at the levels deemed suitable by the regulatory authority. For all drugs, checks are carried out by the manufacturer, which certifies, according to authorized processes, that the individual batch of medicine complies with the specifications. However, there are two other forms of control implemented, particularly in Italy and Europe depending on the type of drug.
Specifically, before their use by the population, vaccines and blood products are checked lot by lot by an Official Medicines Control Laboratory (OMCL) in Europe and then issued a certificate called abatch release, which allows the free movement of the lot throughout Europe. Finally, all the drugs used in Italy, whether biological or chemical, are then subject to a sampling plan from the market for their analytical control.