CGMP文件 风险分析格式SOP

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文件分发部门/编号：（

）

Department of document distributed/Code:

文件变更历史：

History of document changing:

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1 目的Aim

规范风险分析的格式, 和公司内部根据FMEA（失败模式影响分析）方法实施风险分析的方法，最终降低产品的质量风险。

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To standardize the format of risk analysis and methods to carry out risk analysis according to FMEA (Failed Mode Effects Analysis) in internal enterprise, finally to reduce the quality risk of product.

2 范围Scope

在进行工艺验证，设备确认时（包括生产工艺验证、灭菌工艺验证、水制备工艺验证等）时，应根据FMEA方法对验证的过程进行风险分析；在进行重大变更时或引入新的程序时，应根据需要进行风险分析。

During process validation and equipment qualification (including production process validation, sterilisation process validation and water preparation validation , etc.),it’s necessary to do risk analysis to validation process on the basis of FMEA；When carrying through

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important change or inducting new process, use risk analysis when needed.

3 职责Responsibility

3.1 QA部负责建立和更新本SOP

QA Department takes responsibility on establishing and updating this SOP.

3.2 各部门负责相应范围内的风险分析。

Every department take charge of risk analysis in corresponding areas.

3.3 确认/验证委员会负责监督验证/确认时本程序的有效实施。详细内容请见“确认/验证委员会工作描述”（编

码：）。

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Qualification and validation committee sees to implement this process efficiently when supervising validation and qualification .Detailed content can be referred in “Position-related job description - Qualification / Validation committee” (Code:).

4 内容Content

本SOP的内容以FMEA记录表的形式来实施。

Contents of this SOP are implemented in the form of FMEA record tables.

本SOP的内容需通过确认/验证委员会或变更控制委员会通过会议讨论来进行实施.在讨论会上，必须至少有一位生产技术部成员，一位质量保证部成员和一位设备部成员参加。

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This SOP should be implemented after the discussion in the meetings of qualification and validation committee or changing control committee, and there should be a member of production technology department, a member of quality assurance department and a member of equipment department present at least.

4.1 错误/关键参数的收集Collection of wrong and key parameters

需要对所有过程或系统的所有操作/功能参数进行测定，并将各操作项目/功能清楚的列在FMEA记录单中。确认/验证委员会或变更控制委员会的所有在场成员都必须参与此项工作。错误/关键参数收集的基础是：可以导致失败的关键参数或关键步骤的确认。对于每个确认的参数/过程（在FMEA记录单上的参数处给出），应详细评估其可能带来的潜在的失败的影响（在FMEA记录单上的潜在风险处给出）。

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It’s necessary to mensurate all operation and function parameters in all process or system, and list every operation item and function on FMEA record tables .All present members of qualification and validation committee or change control committee must take part in this task. The basis of collecting wrong and key parameters is that it’s qualification of key parameters or key process which may lead to failure. Every confirmed parameter or process (placed at Parameter on the record tables) should be given detailed evaluation on influence brought by possible and potential failure (given at Potential Risk on FMEA record tables).

4.2 潜在失败影响的确定 Confirmation of influence caused by potential failure

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