Good-manufacturing-practice and good-distribution-practice compliance

Good manufacturing practice (GMP) and good distribution practice (GDP) are related aspects of the quality assurance for medicines in the European Economic Area (EEA). The European Medicines Agency plays an important role in coordinating these activities in collaboration with Member States.

Good manufacturing practice

Good manufacturing practice (GMP) is “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 medicines and investigational medicines for human use;
• Directive 91/412/EEC for medicines for veterinary use.

GMP guidelines provide interpretation of these principles and guidelines, supplemented by a series of annexes that modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic.

Compliance with these principles and guidelines is mandatory within the EEA.

Information on GMP inspections coordinated by the European Medicines Agency can be found under coordination of GMP inspections.

Good distribution practice

Good distribution practice (GDP) ensures that the level of quality determined by GMP is maintained throughout the distribution network, so that authorised medicines are distributed to retail pharmacists and others selling medicines general public without any alteration of their properties. The principles of GDP are stated in Directive 92/25/EEC.

GDP should be implemented through a quality system operated by the distributor or wholesaler of medicinal products to ensure that:

• the medicinal products that they distribute are authorised in accordance with European Union (EU) legislation;
• storage conditions are observed at all times, including during transportation;
• contamination from or of other products is avoided;
• an adequate turnover of stored medicinal products takes place;
• 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 products to be found and there should be an effective recall procedure.

For more information, see:

• Guidelines of 7 March 2013 on good distribution practice of medicinal products for human use;
• European Commission: Good distribution practice.

Role of the Agency

The Agency's work involves harmonisation and co-ordination of GMP and GDP activities at an EU level. It is involved in:

• coordinating the preparation of new and revised guidance on GMP and GDP;
• coordinating advice on the interpretation of EU GMP and GDP requirements and related technical issues;
• developing community-wide procedures relating to GMP and GDP inspections, known as the compilation of Community procedures.

This work is carried out in the framework of the GMP / GDP Inspectors Working Group.

The Agency has a coordinating role for all GMP-, product- and process-related inspections of manufacturing sites submitted through the centralised procedure and is involved in the international coordination of GMP inspections of the manufacturers of active pharmaceutical ingredients and finished dosage forms.

The Agency also:

• collaborates in joint projects involving GMP and GDP, both within the EU and externally, including EU candidate countries;
• maintains close contact with organisations such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organization (WHO) and coordinates the input from the EU regulatory side on GMP topics under consideration within the International Conference on Harmonisation (ICH);
• assists in the progression of mutual-recognition agreements on GMP with regulatory authorities in non-EU countries. 

GMP advice

The Agency welcomes questions on its activities and the regulatory framework within which it operates. However, specific questions on the interpretation of GMP requirements or questions concerning products that are not subject to the centralised procedure should be addressed as follows:

• if the product is or will be manufactured outside the EEA, questions should be addressed to the current or prospective qualified person of the EU or EEA batch-releasing site of the product, of, if unknown, to the prospective supervisory authority (the national authority of the Member State where the importer or prospective importer is located);
• if the product is or will be manufactured within the EEA, questions should be addressed to the current or prospective manufacturer's qualified person or the national competent authority of the Member State where the manufacturer is located;
• questions pertaining to the interpretation of EU legislation should be addressed to the European Commission;
• questions pertaining to guidelines issued by other regulators or international organisations, or to technical guides published by industry associations should be addressed directly to the regulator, organisation or association concerned.

Please check the question-and-answer page before submitting a query to gmp@ema.europa.eu.

Table of contents

• Reflection paper on supply shortages
• Other documents of interest
• Concept papers

Reflection paper on supply shortages

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Other documents of interest

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Concept papers

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