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1、1.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
2、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。2. 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
3、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。3. 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. Deviat
4、ions 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
5、、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,
6、 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、
7、 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-preventiveaction.主要偏差需要进行调查，查找问题的根本原因并制定纠正预防措施。A non-critical deviation which potentially affects the quali
8、ty, purity, safety or efficacy of a product/medical device or ability to meet GMP requirements.非严重偏差可能潜在影响产品的质量、纯度、安全、功效或GMP法规的依从性。Minor Deviation :微小偏差：Minor deviation require investigation, root cause analysis and corrective-preventive action. 微小偏差需要调查，查找问题的根本原因并制定纠正预防措施。A deviation not classified
9、 as critical or major, which potentially impacts a GMP system, utility, equipment, material, component, environment or documentation, but does not affect product/medial device quality, purity, safety, or efficacy.潜在影响GMP系统，公用设施，设备、物料、成分、环境或文件，但不影响产品的质 量、纯度、安全、功效，不属于严重及主要偏差的缺陷。Deviations will typical
10、ly, but not exclusively, fall into one of the following categories:- - Confirmed Out of Specification (OOS) test results- - Controlled Zone Environmental results outside of limits- - Failure to comply with instructions in standard documents (Deviation from Standard Operating Procedures, Deviation fr
11、om Batch processing parameters during Manufacture, Packaging, labelling orTesting)- - Process or equipment failure which affects product quality- - Reconciliation or yield outside Specification- - Failure to comply with established program (calibration, preventive maintenance and stability test, etc
12、)Material damage or contamination in storage or handling偏差通常，但不绝对，发生在以下几个类别中：人确认的超出标准的测试结果人受控区域环境超标人不符合标准文件规定的操作(不符合标准操作规程的操作，生产、包装、贴标签或测试过程中操作参数的错误等)人影响产品质量的操作失误或设备故障人物料平衡或产率超过限度人物料在储存或处理过程中出现的损坏和污染情况。人活动未能按照计划进行(校准，预防性维护及稳定性试验等)4. SAFETY 安全N.A.无5. PROCEDURE 程序5.1 RESPONSIBILITIES责任5.1.1 Manufactur
13、ing, Logistic, Engineering,QC,HR Managers 生产、物流、工程部、QC、HR经理 It is their responsibility to immediately notify to QA of the occurrence of any event that could lead to a potential failure event and to actively participate in investigation process其职责为当那些可能导致潜在失误事件发生时，立即通知QA,并积极参与调查活动。 Initiate the Quali
14、ty Deviation Report.起草质量偏差报告 Implementing corrective action resulting from deviation reports when approved by the Head of Quality .执行质量部经理批准的偏差改正措施。 Ensuring all personnel in their Department are trained in the content of this SOP and know that all quality deviations are to be reported.确保本部门人员接受本SOP
15、的培训并清楚所有需要报告的偏差。5.1.2 Site IQC manager is responsible for 质量部经理负责 Ensuring that this SOP is maintained and complies with corporate and local GMP standards. 确保本SOP始终符合集团及中国GMP的要求。+ Approval of corrective action resulting from deviation reports.批准偏差的改正措施。 Approval the disposition of the batch in case
16、of Batch deviations. 当发生批生产偏差时决定批次的处理。 Site IQC Manager is responsible for further communication to the impacted unit and to the respective Operational Industrial Quality and Compliance (IQC) management If the failure or deviation is critical or if other sites/sub-contractors are potentially impacted.如异常事件或偏差程度严重或其他工厂或下级合同商可能受到影响，工厂质量部经理
