GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials: an overview for clinical researchers.
Current gene therapy 2010 Dec; 10(6): 508-15
To be able to produce advanced therapy medicinal products, compliance with regulatory standards while maintaining flexibility is mandatory. For this purpose, careful planning is vital in the design or upgrade of a facility. Similarly, extensive foresight is elemental to anticipate upcoming needs and requirements. Failing this may lead to the facility's in-ability to meet the demands. In this chapter we aimed to outline the current issues with regards to the European Union Directives (EUD) and the proposal for Advanced Therapies, which are of importance to cellular and gene therapy facilities in Europe. This chapter is an attempt to elucidate what the minimum requirements for GMP facilities for cell and gene therapy products are and what is considered necessary to comply with the regulations in Europe.
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Commission Directive 2005/28/EC of 8 April 2005 Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of The Manufacturing or Importation of Such Products Unknown creator (Commission of the European Communities, 1995-04-09)
Draft Commission Directive Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of Manufacturing or Importation Of Such Products Unknown creator (European Commission, 2004-06-14)This proposed directive redrafts the original European Union clinical trials directive (2001/20/EC) that was developed to govern approval and monitoring of commercially-sponsored clinical research in countries of the ...
Mahalatchimy, A (2011-05)The European Union has a public health strategy and will generally ensure in all its policies and activities a "high level of human health protection". The new Regulation (EC) n 1394/2007 on advanced therapy medicinal ...