Work Process and Deliverables
EU-Q-Blood-SOP Manual
 EU-Q-Blood-SOP Manual to assist blood establishments to develop and implement their own SOPs containing
Chapter 1 Background and Objectives
• Requirements defined by 2002/98/EC
• Project Objectives
• Purpose of the Manual (SOP Definition)
Chapter 2:
 Quality principles
linked to the Directive 2005/62/EC with a list of key processes for SOP
Chapter 3:
 Development and Implementation of an SOP
Divided into 6 steps (Chapters 3.1-3.6):
  1. Identify the objective and scope of the SOP and draft a title
  2. Identify the competent user and assign responsibility for writing the SOP
  3. Use the Master SOP to write an SOP
  4. Design a process flow chart and describe each step of the work process in this flow-chart
  5. Initiate document change control
  6. Conduct training in the use of the SOP
Chapter 4:
 SOP Masters and Examples (WG1-4)
covering the critical quality activities in the samples taken from the areas of interest and risk
Annex:
 List of Project-Participants
Directives (2002/98/EC; 2004/33/EC; 2005/61/EC; 2005/62/EC)

References and Definition of • key quality terms linked to the Directive 2005/62/EC
• GMP/GLP best practice terms used in the manual


1ST Edition of the SOP-Manual

Dear colleagues, friends and interested transfusionist

the EU-Q_Blood-SOP transfusion consortium has benn completed the version 1.0 of the SOP manual.
This version can be ordered via 'Blood Manual Ordering' in the left navigation bar.

Further Information will be also available through the EuBIS Project homepage www.eubis-europe.eu

with best regards

yours

Prof. Dr. Erhard Seifried
Prof. Dr. Christian Seidl