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
Good Manufacturing Practice (GMP) sets requirements for the consistent manufacture and control of medicines to appropriate quality standards. In the EU, the framework for human medicines includes Directive 2001/83/EC and Commission Directive (EU) 2017/1572, supported by the detailed guidance in EudraLex Volume 4. The applicable framework depends on the product category.
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.
Following an inspection confirming compliance, the competent authority issues a GMP certificate where appropriate. The certificate reflects the site’s compliance status at the time of inspection. Its current status and any restrictions should be checked in EudraGMDP.
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’s competent GMP inspection offices carry out national and international inspections of pharmaceutical manufacturing and importation sites and manage the related authorisations and GMP certification within their remit.
Following an inspection that establishes GMP compliance and for which a certificate is appropriate, the competent authority should issue the GMP certificate within 90 days of the last day of the inspection.
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.
An authorised AIFA official signs the certificate. A GMP certificate records the site’s compliance status at the time of inspection. It should not be relied on as evidence of current compliance more than three years after that inspection unless the issuing authority has extended its validity. This period may also be shortened by the issuing authority. Check the certificate’s scope, any restrictions and its current status in EudraGMDP.
The general pandemic-related extension of GMP certificates ended after 2024. Any further extension is decided by the competent authority on a case-by-case basis. Check the current certificate record in EudraGMDP and contact the issuing authority where clarification is needed.
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
Quality and manufacturing requirements also apply in other sectors, under their own legislation. Medical-device manufacturers must meet the applicable quality-management requirements of Regulation (EU) 2017/745. Cosmetics must comply with GMP under Regulation (EC) No. 1223/2009; EN ISO 22716 is the relevant harmonised standard. Food and feed operators follow their respective hygiene frameworks, including Regulations (EC) No. 852/2004 and No. 183/2005.
These sector-specific requirements should not be confused with an AIFA GMP certificate for pharmaceutical manufacturing.
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.