The GMP Certificate in Italy

guide on GMP Certificate and why you need it

Learn how you can certify products quality with the GMP.

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.

Table of contents

  1. What is GMP
  2. Legalization of the GMP
  3. Regulatory framework
  4. How Studio A&P can help you
  5. Get a quote

1. 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.

1.1 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.

1.1 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.

1.1.1 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:

  1. the manufacturer inspected by AIFA;
  2. the manufacturing operations carried out by the site;
  3. the importation of medical products, and
  4. 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.

1.2 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.

2. 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:

  1. With apostille, if it is submitted to a Country part of the Hague Convention, given that Italy is part of the Convention as well
  2. 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.

3. Regulatory framework

EU Regulation:

National Transposition:

How we can help you get your documents legalized

  1. Studio A&P replies within 1 business day from your request through our contact form; you will receive a dedicated quotation with timeline and costs needed;
  2. The legalization process starts the same day the quotation is accepted, by paying the quotation fee (through paypal or wire transfer).
  1. First, you have to send the original documents to Studio A&P (in some cases, however, copies of the documents are enough);
  2. After receiving the documents, we will deposit them on your behalf at the competent authorities’ offices;
  3. Finally, once they are ready, Studio A&P sends you back the legalized documents.

 

The timing for apostille a document is around one week, depending on the province.

On the other hand, the timing for the consulate legalization, instead, is around two weeks, depending on the competent consulate.

  1. Full reimbursement 100% if the service is cancelled during the same day;
  2. Reimbursement of 30% after the notification of commencing the legalization process.
 

DHL courier and delivery costs depend on the destination from Italy and are excluded from the quotation.

Please Note: fees for legalization of documents vary based on your needs. Prices start from a minimum of €100,00 and increase based on:

  • Your Country;
  • Translation;
  • Type of document;
  • and other.

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