EDQM-OMCL-检验结果的评价和报告.docx

PA/PH/OMCL(07)28 DEF CORR检验结果的评价和报告?欧洲理事会OMCL网络QUALITY ASSURANCE DOCUMENT质量保证文件PA/PH/OMCL (07) 28 DEF CORREVALUATION AND REPORTING OF RESULTS检验结果的评价和报告Full document title and reference文件全名和索引号Evaluation and reporting of results PA/PH/OMCL (07) 28 DEF CORRDocument type 文件类型GuidelineLegislative basis 立法基础-Date of first adoption首次采用时间October 1999Date of original entry into force首次生效时间February 2000Date of entry into force of revised document修订版本生效时间December 2007Previous titles/other references曾用文件名/其它索引号This document replaces document PA/PH/OMCL (07) 28 DEFCustodian Organisation管理机构The present document was elaborated by the OMCL Network/EDQM of the Council of EuropeConcerned Network 相关网络GEONREPORTING OF RESULTS 结果的报告GUIDELINE FOR OMCLs OMCL指南?1. SCOPE范围This guideline defines basic principles for evaluation and reporting of results of OMCL testing of industrially manufactured medicinal products[1]. The purpose of this OMCL testing is to determine compliance of the 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 the same product in compliance with the specifications.本指南说明了OMCL对工业化生产的药品进行检测的结果的评价和报告原则。OMCL检测的目的是确认产品是否符合上市许可中设定的质量标准和其它相关法规要求。OMCL检测可以认为是对申明其产品符合质量标准的生产商检测的一种验证，?2. INTRODUCTION概述An Official Medicines Control Laboratory (OMCL) performs testing of medicines for human and veterinary use on behalf of the Competent Authority.官方药品化验室（OMCL）代表药监机构对人用和兽用药品进行检测。The testing by an OMCL is performed within the context of activities such as market surveillance studies (MSS), testing of centrally authorised products (CAP), testing of products with mutual recognised authorisation (MRP), official control authority batch release (OCABR) and pre-licensing evaluation. The OMCL should operate the testing in a quality system based on ISO 17025 to guarantee a sufficient level of confidence in the results. The results of th