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.
This rule is valid for both human medicinal products and veterinary medicinal products and AIFA issues GMP certificates for all of these products.
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. Something important about the certificates is that they may be relied upon for three years starting from the date of inspection. After this period of time, companies should consult the issuing authority.
Moreover, the Official Gazette of the Italian Republic publishes the list of the manufacturers AIFA inspected and authorized to produce and control medicines. This list is updated as of June 30th of each year.
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 abroad, manufacturers must legalize it. The legalization of a GMP certificate issued in Italy can be of two types:
- With apostille, if it is submitted to a Country part of the Hague Convention, given that Italy is part of the Convention as well
- Consular legalization, for documents to be presented in countries which are not part of the Convention.
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.