EDQM对实验结果的评估及报告(核心文件).docxVIP

欧洲委员会的OMCL网络质量控制文件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 对实验结果的评估及报告EVALUATION AND REPORTING OF RESULTS核心文件CORE DOCUMENT对于政府药品质控实验室(OMCL)的指导原则GUIDELINE FOR OMCLs1. 范围1. SCOPE本指导原则针对政府药品质控实验室(OMCL)在对工业化生产的药品、中间产品及API进行的检测，定义了在报告结果时的一些基本原则。OMCL进行这种检测的目的是确保该产品能够满足其市场准入时及其他相关法规中建立的质量标准。OMCL的检测可以被看作是生产商宣称该产品符合规定的一种验证。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.为了能够简化对于指导原则的管理，现在的文件中仅包括通用的章节。其附件存在于其他文件中。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.附件的清单包括在本文件中，并且当新的附件发布时这份清单会进行更新。The list of annexes, included in this document, will be updated as soon as new annexes are issued.2. 简介2. INTRODUCTIONOMCL代表管理当局对人用和兽用药品进行检测。An OMCL performs