药品生产中的偏差调查

调


查
Investigation

供应商的信息 Supplier information 外加的测试结果 Testing 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
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 investigated and the conclusion are recorded.
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 approved 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
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 protocol
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 Calibration results on critical instruments or equipment do not meet the approved standards

如何对待偏差 How should we do for deviations

报告 调查 后续检查 归档
Report Investigate Follow up Archive
何谓偏差
ຫໍສະໝຸດ Baidu
What’s 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)
永久变更？
变更控制和 /或验证
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 investigation required, corrective or prevention action(s), and proper disposition of the related material.
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
Product name & lot number may be affected


偏差描述 Description of deviation 已知的原因 Explain deviation as known
报

告
Report
主管按偏差的实际情况将 其分类 Supervisor classify the deviation
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.
偏差分类 Classification
如何对待偏差 How should we do


报告
调查 后续检查 归档
Report
Investigate Follow up Archive
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
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
谁来处理

Who will handle it
药品生产中对偏差的调查 Investigation of Deviation
偏差的调查 Investigation of Deviation

何谓偏差 What’s Deviation

定义 实例 分类
Definition Examples Classification
偏差的调查 Investigation of
Deviation

谁来处理偏差
Who’s 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 responsibility
偏差的调查 Investigation of Deviation


生产操作 包装和贴签 物料管理 设施和设备 实验室控制 质量部门 验证 员工培训
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 departure from their expected ranges
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
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 of investigation.
偏
差
偶发事故 有意偏差 原因已知
原因已知 影响大 原因未知 影响小 原因已知 影响小 原因未知 影响大 影响大 永久变更 影响小 永久变更 原因已知 影响大 原因已知 影响小
无意偏差
影响大 非永久变更
影响小 非永久变更
原因未知 影响小
原因未知 影响大
重大偏差，需调查
非重大，可调查 非重大，不需调查
调

查
Investigation


操作者对程序的知晓和熟练程度 Operator’s 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

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
偏差分类 Classification

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.
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
质量部门

Quality Unit

没有完整的产品质量定期审核报告 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
偏差实例

Deviation Examples
Production Packaging & Labeling Material Management Facilities & Equipment Laboratory Controls Quality Unit Validation Employee Training
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
质量部门 Quality 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
谁来处理 生产作业
Who will handle it Production Activities
调

查
Investigation
若主管将偏差初定为重要偏差，或无法确 定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.