Medicines, vaccines and advanced therapies

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Medicines, vaccines and advanced therapies

Medication control

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 the issued certificate, called batch release, 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.



Back Nuovo standard internazionale per le Immunoglobuline Antitetaniche

Per la determinazione del titolo degli anticorpi anti-tetano nelle Immunoglobuline Umane Antitetaniche, è disponibile per gli OMCL e le ditte produttrici il 2nd Standard Internazionale WHO 13/240.

A questa preparazione, dopo uno studio collaborativo internazionale coordinato dal NIBSC e dall’EDQM ed al quale hanno partecipato 20 laboratori tra cui il CNCF dell’ISS, è stato assegnato un titolo di 45 UI/fiala (report WHO/BS/2019.2367 WHO Biological Standards).

Lo standard è disponibile presso il National Institute for Biological Standards and Control  (NIBSC)
 


Dipartimenti/Centri/Servizi

National Centre for Control and evaluation of medicines

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Citizen Healthcare professional Information specialist

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Document

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Medicines, vaccines and advanced therapies Medication control