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Inspections - Good Manufacturing Practice

Good Manufacturing Practice - Overview

Good Manufacturing Practice (GMP) is defined as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.” The principles and guidelines for GMP are stated in two Directives; Directive 2003/94/EC for medicinal products and investigational medicinal products for human use and Directive 91/412/EEC concerning veterinary medicinal products. Compliance with these principles and guidelines is mandatory within the European Economic Area. Detailed guidelines in the form of the Guide to Good Manufacturing Practice provide interpretation of the principles and guidelines and these in turn are supplemented by a series of annexes which modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic. They are developed by the GMP inspection services group and are published as Volume 4 of EudraLex by the European Commission.

Information on GMP inspections co-ordinated by EMEA can be found by following the GMP Inspection Coordination link.

Good Distribution Practice – Overview

Good Manufacturing Practice ensures that products released for distribution are of the appropriate quality.
This level of quality should be maintained throughout the distribution network so that authorised medicinal products are distributed to retail pharmacists and other persons entitled to sell medicinal products to the general public without any alteration of their properties. To maintain the quality of the products and the quality of the service offered by wholesalers, Directive 92/25/EEC provides that wholesalers must comply with the principles and guidelines of Good Distribution Practice (GDP).

GDP should be implemented through a quality system operated by the distributor (wholesaler) of medicinal products to ensure that medicinal products that they distribute are authorised in accordance with Community legislation, that storage conditions are observed at all times, including during transportation, that contamination from or of other products is avoided, that an adequate turnover of the stored medicinal products takes place and that products are stored in appropriately safe and secure areas. In addition, the quality system should ensure that the right products are delivered to the right addressee within a satisfactory time period. A tracing system should enable any faulty product to be found and there should be an effective recall procedure.

An important part of the Inspections Sector work involves harmonisation and co-ordination of GMP and GDP related activity at Community level. The Sector is involved in co-ordinating the preparation of new and revised guidance on GMP and GDP, co-ordination of advice on the interpretation of EU GMP and GDP requirements and related technical issues, and on the development of community-wide procedures relating to GMP and GDP inspections, known as the Compilation of Procedures. This work is carried out in the framework of the GMP/GDP Inspectors Working Group.

The Sector collaborates in joint projects involving GMP and GDP both within the community and externally including EU candidates. The Sector maintains close contact with organisations such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and WHO and co-ordinates the input from the EU regulatory side on GMP topics under consideration within ICH.

The Sector assists in the progression of MRAs (Mutual Recognition Agreements) on GMP with regulatory authorities in non- EU countries. Details on this aspect of the work are given on the MRA web page.

GMP Advice

While EMEA welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should contact the authority supervising the authorised importer.

Documents of interest:

Documents under consultation

Send all queries regarding this content to: gmp@emea.europa.eu