Quality of medicines and Good Manufacturing Practices (GMP)

 

 

Quality of medicines

Good Manufacturing Practices (GMP) 

Major developments

 

Quality of medicines 

When applying for a marketing authorization, companies, inter alia, must document that the product will be of appropriate quality. On the basis of the documentation submitted competent authorities assess that the criteria set for quality in legislation and guidelines are fulfilled. Legal provisions are included in Annex 1 of Directive 2001/83/EC and Directive 2001/82/EC . In addition, EudraLex Volume 3 includes Scientific guidelines for medicinal products for human use on quality prepared by the Committee for Medicinal Products for Human Use (CHMP) in consultation with the competent authorities of the EU Member States. Similarly, the Committee for Medicinal Products for Veterinary Use (CVMP) has defined which of these and additional specific guidelines should be applicable for the veterinary sector. Those guidelines have been made public with EudraLex Volume 7 Scientific guidelines for medicinal products for veterinary use - 7B Immununologicals/ Quality.

Guidelines are intended to provide a basis for practical harmonisation of the manner in which the EU Member States and the EMA interpret and apply the detailed requirements for the demonstration of quality contained in the Community Directives. Applicants and competent authorities are expected to refer to these guidelines when preparing or assessing an application for a marketing-authorisation.

If the view is taken that the qualitative and quantitative composition of a medicinal product is not as declared, competent authorities shall refuse to authorise a medicinal product for marketing. In the case of products already authorised, competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation. Furthermore, Member States shall take appropriate steps to ensure that the supply of the medicinal product is prohibited and the product is withdrawn from the market (Article 26, 116 and 117 of Directive 2001/83/EC ; Article 30, 83 and 84 of Directive 2001/82/EC ).

Equally important, the European Commission is responsible for publishing the " Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products " . In 2011, a third  technical revision was undertaken to take into account advancement of science in the area of transmissible spongiform encephalopathies, as well as the evolving situation regarding Bovine Spongiform Encephalopathy (BSE) across the world.

Good Manufacturing Practices (GMP)  

The manufacturing or importation of medicinal products, including investigational medicinal products, is subject to a manufacturing or import authorisation. The holder of such an authorisation is obliged to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances (active pharmaceutical ingredients), which have been manufactured in accordance with GMP Part II. (Title IV of Directive 2001/83/EC ); Article 13 of Directive 2001/20/EC, Title IV of Directive 2001/82/EC ).

The Commission has adopted the principles and guidelines of GMP for medicinal products in form of Commission Directive 2003/94/EC concerning medicinal products for human use and investigational medicinal products and Commission Directive 91/412/EEC for veterinary medicinal products. In addition, the Commission has published detailed GMP guidelines in line with those principles in EudraLex Volume 4. In this context, the Commission is revising on a regular basis the GMP guidelines, in collaboration with the European Medicines Agency. The guidelines are revised to take into account the advancement of scientific practices. In 2011, the "Chapter 4 on Documentation" , "Annex 11 on Computerised Systems" and "Annex 14 on Manufacture of Products derived from Human Blood or Human Plasma" have been finalised.

Mutual Recognition Agreement (MRA) with third contries

The Community has concluded MRAs covering the sector of GMP with Switzerland, Canada, Australia, New Zealand and Japan . In line with the scope of each MRA the EMEA has made public areas, including product categories, for which the MRAs have become operational. On the basis of equivalent provisions for GMP and supervision by competent authorities, the EU and the third country mutually accept results of inspections of manufacturers. Furthermore, the qualified person of the importer in the EU may be relieved of his responsibility to carry out the so-called re-testing. For more information consult the following websites: International activities & EMA

Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA)

As a protocol to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States and the State of Israel an ACAA with Israel is currently being discussed with the Member States in the Council. A specific Sectoral Annex will include provisions for the area of GMP. On the basis of implementation of relevant Community legislation for manufacture, importation, official batch release, supervision and inspections results of inspections and official batch release are expected to be mutually recognised by both parties.

 Quality of medicines and Good Manufacturing Practices (GMP) - Major developments