清洁验证风险评估指南！中文部分翻译

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https://mp.weixin.qq.com/s/j1LbuLMsCxE6JHQfZgoFoQ


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翻译：熊

校对：流浪的沙子

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译自2020年8月份发布的《ISPE基准指南：清洁验证生命周期–应用，方法和控制（ISPE Baseline Guide: Cleaning Validation Lifecycle: Applications, Methods, and Controls）》

3 Risk Management

清洁验证风险管理

3.1 RiskManagement Description Overview and Regulatory Expectations

3.1风险管理概览和监管要求

Quality RiskManagement (QRM) is a rational approach to enable good decisions. Cleaningvalidation, like other GMP validation activities, is not exempted from theregulatory expectation of using risk management to control potential hazards,reduce risks, and establish sound cleaning processes. In fact, a risk-basedcleaning validation strategy with justifiable and achievable acceptancecriteria is crucial in attaining a compliant cleaning validation program.

质量风险管理（QRM）是实现良好决策的合理方法。正如其他GMP验证活动一样，清洁验证也需要使用风险管理来控制潜在风险，降低风险，并建立合理的清洁工艺。实际上，基于风险的清洁验证策略以及具有合理且可实现的接受标准，对于获得合规的清洁验证程序至关重要。

Forexample, validation master plans for cleaning should either start with adocumented risk assessment exercise or at least include the risk assessmentprocess in the early stages of developing a new program. In today’s pharmaceuticalregulatory landscape, a retrospective risk assessment is not only a goodpractice, it is expected within cleaning programs, even if that program hasbeen grandfathered as acceptable.

例如，清洁验证主计划应从书面的风险评估活动开始，或者至少在制定新计划的早期阶段就包括风险评估过程。在当今的药品监管环境中，回顾性（倒推式）风险评估不是一种好的做法，而应在清洁计划中采用，尽管历史上它被认为是可以接受的。

3.1.1Regulatory Expectations

监管要求

Quality riskmanagement is a regulatory expectation, as noted in FDA’s Pharmaceutical CGMPsfor the 21th Century [18], which aims to encourage implementation of risk-basedapproaches that focus on critical areas for maintaining or improving productquality.

正如FDA面向21世纪的药品CGMP[18]所指出的那样，质量风险管理是一项监管期望，其目的是鼓励实施基于风险的方法，关注于维持或改善产品质量的关键领域。

Expectationsfor the application of QRM principles to validation are clearly stated inregulatory documents.

法规文件中清楚地说明了QRM原则应用于验证的期望。

For example,EudraLex Annex 15 [4] states applications for QRM in validation:

例如，EudraLex附录15[4]说明了QRM在验证中的应用：

• Todetermine scope and extent of qualification and validation.
• 确定确认和验证的范围和程度。
• To reassessrisks after gaining more knowledge from commercial production.
• 从商业生产中获得更多的知识重新评估风险。
• Todetermine criticality of process parameters.
• 确定关键工艺参数。
• To evaluateplanned changes to determine potential impact.
• 评估计划性变更以确定潜在的影响。
• To justify bracketing approaches.
• 论证括号法的合理性。
• To determine the variable factors which influence cleaningeffectiveness and performance.
• 确定影响清洁效果和性能的可变因素。
• To justifyselected cleaning limits.
• 证明所选择清洁限度的合理性。
• To justifythe number of times the cleaning procedure should be executed (number of runs)for validation.
• 证明清洁程序验证时执行次数的合理性。
• Todetermine the risks presented by microbial and endotoxin contamination duringthe development of cleaning validation protocols.
• 清洁验证方案开发过程中，确定微生物和内毒素污染带来的风险。
  
  

fengshengruby

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