Medicines, vaccines and advanced therapies

TOPIC

Medicines, vaccines and advanced therapies

Checks on compliance with GMP

A key aspect of the production of medicines is the verification of compliance with Good Manufacturing Practice (GMP). By law, this task is entrusted to the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) which makes use of experts from the Istituto Superiore di Sanità (ISS, the National Institute of Health in Italy), mostly from the National Centre for the Control and Evaluation of Medicines and the Biological Service. Following an adequate training process, these experts operate as inspectors and collaborate in teams with AIFA to inspect the numerous pharmaceutical workshops residing in Italy and abroad, in a non-European context managed by the European Medicines Agency (EMA).

The activity is focused both on laboratories that produce pharmacologically active raw materials and on those that produce finished products. The inspection activity plan to verify compliance with the standards of good manufacturing practice at pharmaceutical laboratories is the subject of an agreement with AIFA which manages all requests for the various necessary activities. The Centre, on an accrual basis, coordinates the inspectors of the ISS so that AIFA subsequently organizes, according to its own procedures, the inspection teams, allocating them to the various companies to be inspected. Given the need to inspect an increasing number of pharmaceutical laboratories operating highly advanced production processes, the Centre also supports the recruitment and training of additional experts/inspectors at all ISS facilities to further increase the inspections and thus meet the AIFA requests, given the need to inspect an increasing number of pharmaceutical workshops often characterized by very advanced production processes, as in the case of advanced therapy medicines.


Dipartimenti/Centri/Servizi

Biological service National Centre for Control and evaluation of medicines

Target

Citizen Healthcare professional Information specialist

Topics

Medicines, vaccines and advanced therapies

Le Buone Pratiche di Fabbricazione (Good Manufacturing Practice – GMP)

Le Buone Pratiche di Fabbricazione (Good Manufacturing Practice – GMP) rappresentano un insieme di concetti che individuano aspetti importanti nella produzione di un farmaco. L’applicazione delle Linee Guida GMP non è su base volontaria ma è obbligatoria per legge. Una officina farmaceutica deve essere conforme alle prescrizioni delle GMP, conformità che deve essere confermata attraverso le visite ispettive dell'Autorità Competente, che per l'Italia è l'Agenzia Italiana del Farmaco (AIFA). Le GMP sono, per i farmaci, disposizioni obbligatorie come definito dal decreto legislativo 219 del 2006 e successive modifiche. Il responsabile della produzione in un sito GMP è la “Persona Qualificata” (Qualified Person – QP), nominata in Italia con una determina dall’AIFA. Nell’ambito della EU (e altri paesi con i quali vige un accordo di Mutuo Riconoscimento) le ispezioni effettuate in uno Stato Membro dagli ispettori di quello stato devono essere riconosciute dagli altri Stati Membri.
 


Dipartimenti/Centri/Servizi

National Centre for Control and evaluation of medicines

Target

Citizen Healthcare professional Information specialist

Content type

Document

Topics

Medicines, vaccines and advanced therapies Attività ispettive