Skip to content The Good Manufacturing Practices (GMP) are a set of rules and procedures companies have to comply with to make sure that the manufactured products are of an adequate quality. AIFA (Italian Medicines Agency) is the authority in Italy responsible for coordinating and managing inspections to verify compliance with GMP of manufacturers and importers of active substances.
What is GMP
The Good Manufacturing Practice (GMP) states a set of important aspects in the production of medicines. They first came from the Code of Federal Regulations issued by the American Food and Drug Administration (FDA). This document dates back to 1978 and well explains the fundamental principles companies that produce medicines must follow.
Manufacturers have the obligation to comply with these guidelines. In fact, the competent authority checks that the manufacture of these products complies with the standards and the strict rules based on international regulations.
If everything is in order, the authority issues the GMP certificate. Companies must regularly renew the certificates so as to guarantee the update of the procedures used.
Another way to refer to GMP is cGMP, where the letter c stands for “current”. This refers to the fact that, in order to conform with GMP guidelines, companies must use updated technologies and procedures.
Elements companies should focus on for the GMP
The Good Manufacturing Practice focuses on different activities, not merely linked to the production process.
As a matter of fact, companies should also pay particular attention to:
- Documentation: firms should keep documents in a safe environment to prevent damages;
- Personnel training: manufacturers should properly train employees so that they know how to produce, control and store products;
- Cleaning operations: GMP takes into account criteria for the selection of gear and cleaning products, the correct procedures and the personnel training with reference to this aspect;
- Tools and equipment functioning: companies should pay attention to the correct maintenance of the machineries, that should be designed to prevent products contamination. They should also be strategically placed so as to avoid risks and ensure workers safety;
- Productive process control: this step is important for raw materials and packaging materials to meet the acceptance requirements related to the quality of products;
- Complaints management: companies should make sure to examine and resolve all the complaints related to products adequately.
Moreover, the GMP regulations bring a number of advantages.
The most important ones are:
- Keeping the productive process under control;
- Preventing contaminations and procedure errors;
- Reducing costs, etc.
The role of AIFA for GMP Certificates in Italy
The pharmaceutical industry of the European Union maintains high standards of Quality Management in the development, manufacture and control of medicinal products. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
In Italy, the body that verifies that medicines production follows Good Manufacturing Practice is the Italian Medicines Agency (Agenzia Italiana del Farmaco – AIFA), located in Rome.
The Italian law prohibits the commercialization of medicines without the authorization from AIFA.
In Italy, AIFA is the competent authority for issuing GMP certificates relating to medicinal products for human use and, where applicable, to active substances falling within its competence.
For veterinary medicinal products and active substances for veterinary use, however, the competent authority is the Ministry of Health, in accordance with the applicable legislation and the procedures provided for the veterinary sector.
How AIFA carries out inspections
AIFA relies on experts from the National Institute of Health in Italy (Istituto Superiore di Sanità, ISS) to carry out inspections at pharmaceutical workshops located in Italy and abroad.
Following each inspection, AIFA drafts a report on the producer’s observance of the GMP principles and guidelines. If the inspection meets these requirements, AIFA issues the GMP certificate in the following 90 days.
The certificate includes information about:
- the manufacturer inspected by AIFA;
- the manufacturing operations carried out by the site;
- the importation of medical products, and
- the manufacturing operations of investigational medicinal products.
Finally, an authorized person from AIFA signs the certificates. The GMP certificate is linked to the outcome of the inspection carried out by the competent authority. Normally, the certificate has a three-year validity horizon from the date of the inspection, unless otherwise indicated by the issuing authority or specific circumstances apply.
Since 2025, the general automatic extension introduced during the COVID period for GMP/GDP certificates no longer applies. For this reason, companies should always verify the updated status of the certificate in the EudraGMDP database and, where necessary, consult the issuing authority.
AIFA provides lists and datasets relating to manufacturing sites authorized for the production and control of medicinal products. These lists should be consulted in the most up-to-date version available on the AIFA website or in the relevant official databases, as the information may be subject to periodic updates.
To verify the status of an authorization or a GMP certificate, it is therefore advisable to refer to the updated AIFA source and, where applicable, to the EudraGMDP database.
Further applications of the GMP
Initially developed for medicines, the GMP now applies to medical devices, food, biological derivatives, cosmetics and animal feed.
For instance, as far as food is concerned, the Food Code “Codex Alimentarious” first introduced the GMP. This is a collection of standards, guidelines and codes of practice that companies must follow. Besides, the Codex Alimentarius Commission, which is the central part of the FAO/WHO Standards Programme, also adopts these practices.
Legalization of a GMP certificate
In order to use a GMP certificate issued in Italy abroad, it may be necessary to proceed with an Apostille, consular legalization or translation, depending on the destination country, the authority requesting the document and the nature of the certificate.
In general, an Apostille may be required for countries that are party to the 1961 Hague Convention, while Consular legalization may be necessary for countries that are not party to the Convention or when specifically requested by the competent foreign authority.
Before proceeding, it is therefore always advisable to verify the local requirements applicable in the destination country and with the requesting authority.
If you are looking for further information on the legalization process and how Studio A&P can help, you can have a look at our dedicated service page about legalization and apostille of documents.