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