GMP, GCP and IRIS guides

The guide for applicants and Marketing Authorization Holders (MAH) involved in GMP and GCP inspections coordinated by the EMA as well as the IRIS guide have been updated.

Good Manufacturing Practices (GMP) are the principles and guidelines that a manufacturer of medicinal products for human or veterinary use must follow in its production processes.

Good Clinical Practice (GCP) is a set of ethical and scientific quality requirements that must be met when testing medicines.

All medicines placed on the European market must obtain a Marketing Authorisation (MA). During the process of obtaining the MA, the compliance of the medicinal product with the quality, safety and efficacy requirements is assessed by a competent authority.

An authorisation also exists for the manufacture of medicines. This authorisation ensures that medicinal products authorised on the EU market are manufactured and imported only by authorised manufacturers whose activities are subject to regular inspections by the Competent Authorities (CA).

Good Manufacturing Practice (GMP) require that medicines :

  • be of consistently high quality
  • are suitable for their intended use
  • meet the requirements of the Marketing Authorization or clinical trial authorization

GMPs are an enforceable legislative reference for inspections of pharmaceutical companies by Competent Authorities.

In order to maintain the harmony of legislation at European level, the European Commission adopts directives establishing the principles and guidelines of GMP for medicinal products in the EU. The European Medicines Agency (EMA) also plays a key role in coordinating and harmonising GMP activities at EU level and coordinates inspections of manufacturing sites of medicinal products for which marketing authorization is applied for through a centralized procedure or under a referral procedure.

These inspections are requested by the Committee for Medicinal Products for Human Use (CHMP) and/or the Committee for Medicinal Products for Veterinary Use (CVMP) in order to verify compliance with Good Manufacturing Practice of sites responsible for the manufacture of medicinal products.

Good Clinical Practice (GCP) inspections are requested by the Committee for Medicinal Products for Human Use (CHMP) to verify compliance with Good Clinical Practice for centrally authorised medicinal medicines.

Applicants and Marketing Authorisation Holders (MAHs) must use the EMA's IRIS system to communicate with the EMA on GMP inspections requested by the Agency's scientific committees.

IRIS is a secure online platform to follow the scientific and regulatory procedures for medicinal products with the EMA.

Guidance:

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