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):

• Identify the objective and scope of the SOP and draft a title
• Identify the competent user and assign responsibility for writing the SOP
• Use the Master SOP to write an SOP
• Design a process flow chart and describe each step of the work process in this flow-chart
• Initiate document change control
• 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