OMCL Network of the Council of Europe
QUALITY ASSURANCE DOCUMENT
PA/PH/OMCL (05) 47 DEF
VALIDATION OF ANALYTICAL PROCEDURES
Full document title and
reference
Validation of Analytical Procedures
PA/PH/OMCL (05) 47 DEF
Document type
Guideline
Legislative basis
The present document was also accepted by EA as
recommendation document to be used in the context of Quality
Management System audits of OMCLs
Date of first adoption
October 1999
Date of original entry
into force
February 2000
Date of entry into force
of revised document
June 2005
Previous titles/other
references
This document replaces document PA/PH/OMCL (99) 37 DEF
Custodian
Organisation
The present document was elaborated by OMCL
Network/EDQM of the Council of Europe
Concerned Network
GEON
PA/PH/OMCL (05) 47 DEF - OMCL Guideline on Validation of Analytical Procedures
June 2005
Page 1 of 8
VALIDATION OF ANALYTICAL PROCEDURES
GUIDELINE FOR OMCLs
INTRODUCTION
The two ICH Guidelines on “Validation of Analytical Procedures: “Definition/ Terminology
and Methodology” (Q2A and Q2B) constitute a discussion of the validation characteristics
that should be considered during the validation of an analytical procedure (the guideline has
also been adopted for veterinary products during VICH discussion). They are primarily
addressed to pharmaceutical industry indicating which validation data need to be provided in
an application file. These data should demonstrate that the proposed testing and acceptance
criteria are sufficiently under control to guarantee reproducible quality of the products at
release and adequate control during shelf-life (stability).
As the circumstances under which an OMCL works are different from those of a
pharmaceutical company – in most cases no routine analysis, but often responses to be made
in a short period of time -, the extent of analytical validation requested before performing an
analysis needs to be reconsidered. On the other hand it has in all cases to be guarantee