evaluation_reporting_of_results_core_document.pdfVIP

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