Good manufacturing practice

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This content applies to human and veterinary medicines.

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.

Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.

GMP requires that medicines: 

  • are of consistent high quality;
  • are appropriate for their intended use;
  • meet the requirements of the marketing authorisation or clinical trial authorisation.

Agency role

The Agency has a coordinating role for GMP inspections of manufacturing sites for medicines whose marketing authorsation in the EU is submitted through the centralised procedure or as part of a referral procedure.

The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level. It is involved in:

  • coordinating the preparation of new and revised guidance on GMP;
  • ensuring common interpretation of EU GMP requirements and related technical issues;
  • developing EU-wide procedures on GMP inspections and related activities;
  • facilitating cooperation between Member States for inspections of manufacturers in third countries.

Legal framework and guidelines

Three legal instruments lay down the principles and guidelines of GMP in the EU:

In addition Directive 2001/83/EC and Directive 2001/82/EC lay down related provisions.

The EU 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.

Manufacturing authorisation

Manufacturers and importers located in the European Economic Area (EEA) must hold an authorisation issued by the national competent authority of the Member State where they carry out these activities.

They must comply with EU GMP to obtain a manufacturing or import authorisation. They can ensure that they meet all their legal obligations by following the EU GMP guidelines.

Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP. 

Registration of manufacturers of active substances

Manufacturers of active substances intended for the manufacture of human medicines for the EU market must register with the national competent authority of the Member State where they are located.

Active substance manufacturers must comply with GMP. In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP. 

Importers of active substances intended for the EU market are also required to register. In addition, each consignment needs to be accompanied by a confirmation by the competent authority of the country where it is produced that it conforms to GMP standards equivalent to those in the EU, unless a waiver applies.

Responsibility for inspections

In the EU, national competent authorities are responsible for inspecting manufacturing sites located within their own territories.

Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned. If an MRA applies, the authorities mutually rely on each other's inspections. 

If products are imported directly into more than one Member State from a manufacturing site outside the EU, there may be more than one national competent authority responsible for inspecting it. EMA facilitates cooperation between the authorities concerned in supervising the site.

EU competent authorities plan routine inspections following a risk-based approach, or if there is suspicion of non-compliance.

EudraGMDP database

EudraGMDP is a publicly accessible EU database which contains manufacturing and import authorisations, registration of active substance manufacturers, GMP certificates and non-compliance statements.  

After inspecting a manufacturing site, EU competent authorities issue a GMP certificate or a non-compliance statement, which is entered in the EudraGMDP database.

GMP/GDP Inspectors Working Group

EMA chairs and provides the secretariat for the GMP/GDP Inspectors Working Group of senior inspectors appointed by all the EEA competent authorities. It meets at EMA four times a year. 

The European Commission and observers from EU accession coutnries, mutual recognition partner authorities, the European Directorate for the Quality of Medicines and HealthCare and the World Health Organization also attend the working group's meetings.

The group provides a forum for harmonisation and discussion of common issues, such as:

  • updates or amendments to the EU GMP guidelines;
  • the compilation of Union procedures;
  • harmonised interpretation of GMP and related requirements.

Compilation of Union procedures

EMA maintains a compilation of GMP and good distribution practice (GDP) inspection-related procedures and forms agreed by all Member States. This facilitates cooperation between EU Member States and supports harmonisation and exchange of  inspection-related information. 

It covers the basis for national procedures that form part of the national inspectorates’ quality systems:

EMA published the Word version of some of the templates for the convenience of inspectorates:

Inspections for pharmaceutical starting materials 

Plasma master file (PMF) inspections

For products derived from blood or blood plasma, EMA is responsible for coordinating inspections of the blood establishments in which collection, testing, processing, storage and distribution is carried out under the PMF certification procedure. 

For more information on the PMF certification procedure, see Plasma master files.

Vaccine antigen master file (VAMF) inspections

EMA is responsible for coordinating inspections of vaccine antigen manufacturing sites under the VAMF certification procedure.

For more information on the VAMF certification procedure, see Vaccine antigens.

Mutual recognition agreements

The EU has signed mutual recognition agreements on GMP inspections with regulatory authorities outside the EU. This allows EU authorities and their counterparts to:

  • rely on each other's GMP inspections;
  • waive batch testing of products on entry into their territories;
  • share information on inspections and quality defects.

The scope of each agreement differs. 

More information

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Contact point:

gmpinsp@ema.europa.eu