Edition 1.0.1 of the EuBIS Manual and guide including references to GMP and Good Practice Guideline (CoE guide and Directive 2016/2014)

1.Oct. 2016

The EuBIS Manual and guide have been developed by the participants of the EuBIS Project co-funded by the European Commission, Health and Consumer Protection Directorate General, Public Health and Risk Assessment Directorate, DG Sanco Grant Agreement No. 2006202. (2003-2008) The guide gives valuable information and guidance on common criteria and standards for the inspection of blood establishments based on the requirements set-out in the blood legislation of the European Commission. It refers also to references giving Standard to set-up Quality Management Systems based on GMP and GPG. Further information on this manual including updated versions, national training courses or seminars organised by the project participants is available from the project Website of EuBIS (European blood inspection system) (www.eubis-europe.eu). The EuBIS project clearly recognises that additional inspection standards are used throughout Europe. These standards reflect in part legal requirements defined by individual EU Member States or are required internationally. In particular, good manufacturing practice (GMP) standards are the basis for inspections carried out by competent authorities as well as blood establishments. The training guide, therefore, provides clear references to relevant GMP standards and refers to other commonly applied standards and guidelines within the EU, such as the - PIC/S guidelines - CoE (EDQM) guide including the Good Practice Guideline (Directive 2016/2014) - revised GMP Annexes (Eudralex)

Based on COMMISSION DIRECTIVE (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments. Official Journal of the European Union, L199/14, 26/07/2016 the EuBIS Manual and guides have been revised by including updated references to GMP (Eudralex) and GPG (referring to the CoE guide)

The Edition 1_0_1 EuBIS Manual and Guide are available os PDF or Hard-Copies via the EubIS Homepage.

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