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evaluation_reporting_of_results_core_document
1/6
OMCL Network of the Council of Europe
QUALITY ASSURANCE DOCUMENT
PA/PH/OMCL (13) 113 2R
Evaluation and Reporting of Results
Core document
Full document title and
reference
Evaluation and Reporting of Results – Core Document
PA/PH/OMCL (13) 113 2R
Document type
Guideline
Legislative basis
/
Date of first adoption
October 1999
Date of original entry
into force
February 2000
Date of entry into force
of revised document
October 2014
Previous titles / other
references / last valid
version
This document replaces document PA/PH/OMCL (07) 28 DEF
CORR
Former titles / references:
Evaluation and Reporting of Results from Assays, PA/PH/OMCL
(02) 52 DEF
Evaluation and Reporting of Results, PA/PH/OMCL (99) 38 DEF
Custodian
Organisation
The present document was elaborated by the OMCL Network /
EDQM of the Council of Europe
Concerned Network GEON
PA/PH/OMCL (13) 113 2R
2/6
EVALUATION AND REPORTING OF RESULTS
CORE DOCUMENT
GUIDELINE FOR OMCLs
1. SCOPE
This guideline defines basic principles for evaluation and reporting of results of Official
Medicines Control Laboratory (OMCL) testing of industrially-manufactured medicinal
products1, extemporaneous products and APIs. The purpose of this OMCL testing is to secure
compliance of a product with the specifications laid down in the Marketing Authorisation and
other relevant regulations. The OMCL testing can be considered as a verification of the
testing by the manufacturer who has declared that the same product is in compliance with the
specifications.
In order to simplify the management of the guideline, the present document contains only the
general chapters. The annexes can be found in separate documents.
The list of annexes, included in this document, will be updated as soon as new annexes are
issued.
2. INTRODUCTION
An OMCL performs testing of medicines for human and veterinary use on behalf of the
Competent Authority.
The testing by an OMCL is p
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