药品生产中的偏差调查

1、.,1,药品生产中对偏差的调查Investigation of Deviation,.,2,偏差的调查 Investigation of Deviation,何谓偏差 Whats Deviation 定义 Definition 实例 Examples 分类 Classification,.,3,偏差的调查 Investigation of Deviation,谁来处理偏差 Whos going to deal with deviations 质量部门的职责 Quality unit(s) responsibility 生产作业的职责 Production Activities responsi

2、bility,.,4,偏差的调查 Investigation of Deviation,如何对待偏差 How should we do for deviations 报告 Report 调查 Investigate 后续检查Follow up 归档 Archive,.,5,何谓偏差 Whats Deviation,对批准的指令或规定的标准的偏离。 Departure from an approved instruction or established standard. (ICH API GMP Guide),.,6,偏差实例 Deviation Examples,生产操作 Producti

3、on 包装和贴签 Packaging & Labeling 物料管理 Material Management 设施和设备 Facilities & Equipment 实验室控制 Laboratory Controls 质量部门 Quality Unit 验证Validation 员工培训Employee Training,.,7,生产操作 Production,关键工艺参数的实际值超出规定范围 Actual results for critical process parameters exceed their specified range 实际产率偏离预期范围 Actual yields

4、 departure from their expected ranges,.,8,包装和贴签 Packaging & Labeling,所用包装材料无法追溯 The packaging materials used are not traceable 发出,使用和退回标签无法平衡 The quantities of labels issued, used, and returned are not reconciled,.,9,物料管理 Material Management,物料供应商未经质量部门核准 The material is not from the supplier approv

5、ed by the quality unit 物料容器上没有标上指定的编号、批号或接受号 The containers of material are not identified with the assigned distinctive code, batch, or receipt number,.,10,设施和设备 Facility & Equipment,设施或设备的破损可能会影响产品质量The damage on facility or equipment with potential impact on product quality 关键仪器设备的校验结果不符合规定的标准 Ca

6、libration results on critical instruments or equipment do not meet the approved standards,.,11,实验室控制 Laboratory Controls,实际测试结果不符合质量规格 Actual testing results are Out Of Specifications 所用的物料或仪器超出其有效期 The materials or instrument used are out of their expiration dates,.,12,质量部门 Quality Unit,没有完整的产品质量定期

7、审核报告 No complete regular quality reviews of API 没按规定进行内部审计（自查）Internal audits (self-inspection) are not performed in compliance with the program,.,13,验证 Validation,对验证方案中关键参数范围的偏离，或结果不符合规定的认可标准 Departure from the parameter ranges of critical steps or acceptance criteria in the approved validation pr

8、otocol,.,14,员工培训 Employee Training,员工不具备与其工作相称的教育、培训和/或经历等资格 Employees are notqualified by appropriate education, training and/or experience for their job.,.,15,偏差分类 Classification,从偏差的发生来分通常有三种 Deviations may occure in 3 classes 偶发事故 Incidential 有意偏差 Intentional 无意偏差 Unintentional,.,16,偏差分类 Classif

9、ication,根据偏差的潜在影响可分为重大的和非重大的 Deviations may be typed as critical or noncritical based on their potential effects.,.,17,偏差分类 Classification,重大偏差 Critical deviation 必须进行调查 Require an investigation 非重大偏差 Noncritical Deviation 可以进行调查 May require an investigation,.,18,谁来处理 Who will handle it,质量部门 Quality

10、 Unit(s) 确保已经对重大的偏差进行了调查，并已解决。 Making sure that critical deviations are investigated and solved,.,19,谁来处理 Who will handle it,生产作业 Production Activities 确保所有的生产偏差都已报告、评价，对重大的偏差已做了调查，并记录结论。Making sure that all production deviations are reported and evaluated and that critical deviations are investigat

11、ed and the conclusion are recorded.,.,20,如何对待偏差 How should we do,报告 Report 调查 Investigate 后续检查Follow up 归档 Archive,.,21,报 告 Report,发现偏差的员工及时记录下列信息并报告主管 Record the following information & report to supervisor immediately: 时间、地点 Time & place 会受影响的产品及其批号 Product name & lot number may be affected 偏差描述 D

12、escription of deviation 已知的原因 Explain deviation as known,.,22,报 告 Report,主管按偏差的实际情况将其分类 Supervisor classify the deviation,.,23,偏 差,偶发事故,有意偏差,无意偏差,重大偏差，需调查,非重大，不需调查,非重大，可调查,原因已知,永久变更？,变更控制和/或验证,.,24,报 告 Report,记录不需调查的偏差的原因、纠正或预防措施，以及相关物料的处理意见 Record the assignable cause for deviations with no investi

13、gation required, corrective or prevention action(s), and proper disposition of the related material.,.,25,报 告 Report,主管在作决定前可咨询有关人员Supervisor may consult with related person(s) 主管签署记录并按规定流转审核Supervisor signed the record and circulates for review or approval,.,26,调 查 Investigation,若主管将偏差初定为重要偏差，或无法确定

14、偏差的原因或是否有不良影响，应立即会同质量部门进行调查。 If the initial examination by supervisor determines the deviation as critical, or it cannot determine an assignable cause or provide assurance of not having negative impacts, an investigation must be undertaken jointly by quality unit and the supervisor immediately.,.,27

15、,调 查 Investigation,质量部门发出偏差调查表，除了登录偏差记录表号或其主要情况外，根据偏差具体情况，记录下列部分或全部调查内容。Quality unit issues a deviation investigation form. Besides the number of deviation record form or its main information, part or all of the following investigation information should be recorded according to the individual case

16、of investigation.,.,28,调 查 Investigation,操作者对程序的知晓和熟练程度 Operators familiarity and comfort lavel with procedures 主记录文件和/或SOP的清晰和准确度Clarity and accuracy of Master Record documentation and/or SOP 查阅有关的记录 Review appropriate executed records,.,29,调 查 Investigation,供应商的信息 Supplier information 外加的测试结果 Test

17、ing results conducted additionally 内部审计（自检）报告 Internal audit (self-inspection) reports 资源分配情况及其有效性 Resource allocation and availability,.,30,调 查 Investigation,满足下列两个条件后调查才能作结论 The investigation should not conclude until the following two conditions are satisfied 偏差的原因及纠正和预防措施已确定 An assignable cause

18、of the deviation and corrective and preventive action are determined 对物料的影响已确定 Impacts to related material are determined,.,31,后续检查 Follow-up,质量部门以及与偏差有关的部门应确保纠正和预防措施已经执行和或落实 Quality Unit and the department(s) related to the deviation should be responsible to ensure that Corrective and preventive ac

19、tion completed and/or arranged.,.,32,后续检查 Follow-up,作必要的变更验证 Necessary Changes/Validations 进行必要的培训 Necessary Training,.,33,归 档 Archive,归档的文件应包括下列内容： The following documents should be archived for the deviation: 有物料处理的完整的偏差报告 Completed Deviation Report with material disposition,.,34,归 档 Archive,偏差调查表

20、 Deviation investigation form 纠正及预防措施表 Corrective and preventive Action form 该签的名都已签好 All required signatures have been obtained,.,35,归 档 Archive,偏差的归档可用下列不同的方法，只要有书面程序规定用哪种方法： The documents of deviation may be archived in the following ways, as long as it is defined in a written procedure.,.,36,归 档 Archive,所有报告归入批生产测试记录，质量部门只有偏差登记，若要看报告，就查批记录； All deviation documents are kept with