What are good manufacturing practices?

What are Good Manufacturing Practices?

Good Manufacturing Practices (GMP) are the principles and guidelines to be respected for the manufacture of medicinal products for human and veterinary use.

Before being placed on the market, medicinal products are subject to the marketing authorisation system, which guarantees that all medicinal products for human or veterinary use have been evaluated by a competent authority to ensure that they comply with quality, safety and effectiveness requirements.

At manufacturing level, there is also a manufacturing authorisation system that guarantees that all medicinal products authorised for the European market are only manufactured and imported by authorised manufacturers whose activities are subject to regular inspections by the competent authorities and who implement the quality risk management principles.

The GMP applicable to medicinal products are a legislative reference enforceable during inspections of pharmaceutical undertakings performed by the competent authorities.

In Belgium, the competent authority is the Federal Agency for Medicines and Health Products (FAMHP). GMP inspections are performed by a team of inspectors from the FAMHP DG Inspection Industry Division.

The pharmaceutical industry within the European Union (EU) maintains a high level of quality management in the development, manufacture and inspection of medicinal products and their active pharmaceutical ingredients. The GMP are an essential component of the general medicinal product quality guarantee system implemented by the pharmaceutical companies.

European harmonisation

In the EU, all manufacturers of finished or intermediate, experimental or commercial medicinal products, for human or veterinary use, must hold a manufacturing authorisation, whether the medicinal products are destined for the European market or for exportation.

So as to maintain harmony in European legislation, it is the European Commission that adopts the directives establishing the principles and guidelines of the GMP for medicinal products and similar. 

The particular guidelines complying with these principles are published in the guide to GMP, available on the European Commission website: volume 4 of the EU guidelines to GMP Medicinal Products for Human and Veterinary Use.

Other regions of the world apply other rules very similar to the European GMP, such as GMP 21CFR Parts 210 and 211 (Food and Drug Administration) in the United States.

Last updated on 07/09/2018