审核与监控清洁过程的质量风险管理方法.pdfVIP

A quality Risk Management Approach to Review and Monitor Cleaning Process 审核与监控清洁过程的质量风险管理方法 作者： lan Campbell and Dominic Thibeault 翻译： 刘慧 上海迪赛诺生物医药有限公司 Cleaning Processes should be continuously monitored and evaluated at defined intervals and re-validated as necessary. Further assurance of control also can be gained through monitoring routine production, including using Process Analytical Technology (PAT), where applicable. 清洁过程应当持续监控且在特定的时间间隔内评估及再验证。在日常的生产过程 中，可以运用PAT 使得清洁过程得以控制。 The application of quality risk management principles can effectively address requirements for cleaning process reassessment and revalidation. A systematic quality risk assessment can serve to identify where additional oversight might be required as well as serving as a guide to the extent of the oversight. 质量风险管理原则的运用能有效地解决清洁过程重新评估与再验证的需要。系统 性的质量风险评估能用来鉴别哪些地方需要加强监控。 A holistic approach to the review of cleaning programs should be taken to ensure adequate controls continue to be in place after the initial cleaning validation studies have been completed. A high level risk review or Preliminary Hazards Analysis (PHA) of the operational and environmental controls is performed as a preliminary step. This is followed by a detailed quality risk assessment of the cleaning process itself using a Failure Modes and Effects Analysis (FMEA) approach to assess the risk associated with the cleaning process and identify if and where any risk mitigation measures might be needed. 系统的清洁验证程序审核确保清洁验证完成后监控仍继续。操作和环境的风险审 核或者预先危害分析是操作的第一步。接下来用 FMEA 工具对清洁过程做详细 的质量风险评估，鉴定哪些地方需要风险控制。 This article presents a risk –based approach to periodic revalidation of cleaning procedures as an approach to maintaining the validated state. The applicati