使用软件系统推动 CPV 计划取得成功

白皮书

想要更智能的生产数据管理?关键在于利用软件系统推动 CPV 计划取得成功。

本文将帮助您简化寻找合适系统的过程。它就如何将专用数据管理系统纳入 CPV 计划以满足 FDA 要求并保护和改进您的业务提供了重要见解。白皮书参考了 BPOG 的 "持续工艺验证文件及计划示例 "中讨论的许多必要元素

要点 

  • CPV 需要适当的规划
  • 正确的产品数据管理系统能以最少的资源收集 CPV 所需的特定数据并将其转化为必要的产出
  • 了解 CPV 规划的组成部分,从系统中获取最大价值

Why is continued process verification important?

An area of life science that has recently received significant attention around data, its integrity and management processes, is manufacturing. One key contributor to this focus is the 2011 publication of the FDA’s “Process Validation: General Principles and Practices.” Within this guideline for process validation, the third and final stage of process validation – “Continued Process Verification (CPV)” – states that manufacturers must provide continual assurance that their manufacturing process remains in control over time. Each manufacturer must put plans and processes in place to collect and analyze end-to-end production and process data to ensure product outputs are within predetermined quality limits. The plan must also ensure the process remains in statistical process control (SPC) – noting that while there may not be “failures” of an individual batch, a process may start to drift out of control, leading to the likelihood of future batch failures. The goal of SPC, and its incorporation into CPV, is to prevent those failures from occurring.

观看演示

更多白皮书