EUBIS

EU-SOP
Standard Operating Procedure (SOP) Page 1 of 4
Scope: Institution / Department (Name the department or unit issuing the SOP)
SOP:
Document-ode (e!g! EU-SOP)
Document-"ersion (e!g! "ersion 1!#)
$it%e: EUBIS SOP &aster Document
"a%id from:
Effective date.
Expiry date.
A document control procedure must be established to guarantee a regular
revie of documents and to !eep the history of documents (previous
versions).
'ep%aces "ersion:
"ocument#$ode and "ocument#%ersion
(anges:
# Please describe&list the relevant changes that have been made in
comparison to the previous version of the document
# 'easons for changes
Distri)utor:
Original( )uality management office
$opy#*dentification Number
(Example)( +, -, . etc.
the use of electronic copies is optional
*ritten )+: 'e,ie-ed and aut(orised )+:
"ate( "ate(
Name of person(s) Name of person(s)
/ile name( -012+2234.doc
EUBIS
EU-SOP
Standard Operating Procedure (SOP) Page . of 4
Scope: Institution / Department (Name the department or unit issuing the SOP)
1! O)/ecti,e
.! 0rea of app%ication

1! 'o%es co,ered )+ t(e SOP (5ob description, personnel responsibilities)
Name of the !ey personnel involved in the process covered by the SOP including the responsible&6ualified
persons (as defined by the "irective7s).
8his information can be alternatively given in the site#master file and&or handboo! according to the
organisational chart and&or 5ob description.
4! Description Operating Procedure
4!1 Process 2%o--(art
4!. Define ritica% Points ('is3 ana%+sis)
4!1 Description of t(e -or3 acti,ities
/ile name( -012+2234.doc
EUBIS
EU-SOP
Standard Operating Procedure (SOP) Page 1 of 4
Scope: Institution / Department (Name the department or unit issuing the SOP)
4! Procedure for 5on onformance ($ommission "irective -443&9-&E$ : Art. 1)
"efine measures or regulation to be ta!en if there are deviations from the defined or!ing description or in case
of unexpected errors.
8he corrective and preventative action system should ensure that existing product nonconformity or 6uality
problems are corrected and that recurrence of the problem is prevented. 8he blood establishment should have
methods and procedures in place to input product or 6uality problems into corrective and preventative action
system.
'e6uirements for these 6uality elements are not sub5ect to this document level (SOP). *n general these
regulations are included on a higher ran!ed document level (e.g )uality management handboo!&Site#;aster
/ile&<eneral Procedure).
6! Documentation
8he documentation of procedures and records is essential to a 6uality assurance system. *t ensures that or!
performed is standardised, and that there is a traceability of all steps in the collection, manufacturing, testing,
release&issuing, storage and distribution of blood components.
All records shall be !ept for a minimum of .4 years ("irective -44-&1=&E$).
/ile name( -012+2234.doc
EUBIS
EU-SOP
Standard Operating Procedure (SOP) Page 4 of 4
Scope: Institution / Department (Name the department or unit issuing the SOP)
7! 0nne8
- 9iterature (e.g Publications in peer revieed 5ournals)
- 'eferences (e.g. ;anufacturer manuals, test procedure descriptions)
- $ermino%og+
- re%ated SOP-Documents (e.g E6uipment log#boo!s)
- 'ecords and/or protoco%s used for documentation
(e.g. /orm sheets used in this SOP, $leaning and desinfection plan, donor recall record)
Important re:uirements to )e referred to in t(e SOP:
- Directi,e .##./;</E
- =ua%it+ manua% / Site &aster 2i%e (according to Annex * Part >, Art ++(+), "irective -44-&1=&E$)
- ommission Directi,e .##4/11/E
- ommission Directi,e .##4/61/E
- ommission Directi,e .##4/6./E
- 5ationa% %egis%ation
- 5ationa% guide%ines
Important notice :
8he aim of this pro5ect is not to provide a operating procedure to be used in an institution, but rather to provide
the tools by hich one can build up an standard operating procedure (SOP). 8he idea is to provide a logical
frameor! hich can be used by all institutions in a variety of different logistical and functional situations.
8he E?>*S SOP#;aster is thought to give an example on ho to set#up a SOP folloing best practice for blood
establishments based on the E? blood legislation ("irective -44-&1=&E$ and -443&9-&E$).
/ile name( -012+2234.doc