GMP偏差处中英文.doc

PURPOSE 目的 Whenever a product, material or system fails to meet the specifications or in the event of a failure to comply with relevant documentation or regulatory requirements, an appropriate investigation must be undertaken, the cause(s) identified and the necessary corrective actions taken 当产品、物料或系统不符合质量标准要求或某事件不符合相关文件或法规要求时，必须进行适当的调查，查明原因并采取必要的改正措施。 SCOPE 范围 This SOP covers all failures and unplanned incidents related to Chemical components, Packaging materials, Drug Products, Processes, Systems, Equipments, Utilities and Facilities used to produce and control them. 本SOP适用于处理所有失误及非计划性故障事件，含概用于产品并控制产品的化学成分、包装材料、药品、工艺、系统、设备、公共设施和厂房等。 DEFINITIONS/ABBREVIATIONS 定义/缩写 Deviation（also known as anomaly）：Any unplanned change from a written procedure/document, during manufacturing or testing or a non-conformance to approved specifications or any failure on GMP-related systems. Deviations are assessed according to compliance and /or the risk they present to patient health and/or with regulatory requirements. Deviations are to be classified as “critical or major or minor” 偏差（通常也称为异常）：在药品生产过程中，任何与既定的程序、文件不符的非计划的变更或与批准的质量标准不符，或与GMP相关的系统失败。偏差按照对患者造成的风险何国家法规的符合性进行评估。偏差可分为三类“严重偏差、主要偏差、微小偏差” Critical Deviations: 严重偏差： Critical deviations require immediate investigation, root cause analysis and corrective-preventive action. 严重偏差需要立即进行调查，查找问题的根本原因并制定纠正预防措施。 A deficiency in material, drug product, medical device, system or service that can affect significantly the quality, purity, safety or efficacy of a product/medical device or can lead to health threatening conditions in drug product, or medical device. Alternatively, any deficiency that can lead to a non-compliant drug product/medical device or to a situation that may be cited by regulatory authorities as critical. 存在物料、产品、医疗器械或任何系统、维护方面能严重影响产品质量、纯度、安全、功效，能对产品或身体健康产生危害的缺陷；或者会导致产品质量不符合，或可能被法规部门视为严重缺陷项的缺陷； Major Deviation: 主要偏差： Major deviations require investigations, root cause analysis and corrective-preventive action. 主要偏差需要