What are GMP?

The Good Manufacturing Practices (GMP) are a guideline that describes the minimal qualitative aspects required to the production, control and release of a Pharmaceutical product, intended as a Drug in its final formulation, or as an Active Pharmaceutical Ingredient (API).

The Aim of the GMP is to ensure that a Drug is produced, checked and released according to a certified quality system, in order to minimize uncontrolled risks for the patients.

Several chapters and specific annexes form an integral part of the GMP. Specific chapters are focused on the different aspects of a Pharmaceutical Company that could have influence on the Quality of the Drug, such as Production, Quality Control tests, Warehouse and Subcontractors.

Among the annexes, Annex 1 represent the main reference for Aseptic processes; Annex 2 is related to Biological Products and Annex 13 deeply focused on Investigational Medicinal Product.

GMP compliance of Pharmaceutical companies is checked every two years by the Regulatory Agencies (AIFA for Italy), that, after an audit performed by trained inspectors, produce a decree regulating and allowing the company to produce Drugs.

The compliance to the GMP is required by the European Directive 2003/94/EC, and by its Italian receipt D.Lvo 219/2006.

According to European Directive 2001/20/EC and its Italian receipt D.Lvo 211/2003, GMP application, and compliance, is not just required for Drugs distributed on the Market, but for investigational products as well.

Rule 1394/2007/EC states that Advanced Therapies Products, such as Gene or Cellular Therapies products, must considered as Drug, and so GMP compliance must be respected