6.5 Knowledge Management
知识管理
The effective and efficient capture and analysis of process-related information is essential to process understanding and validation. Information that supports process validation should be identified, analyzed, communicated, maintained, and available. It is important to recognize that knowledge management is not
just data collection. It involves a strategic, systemic, and methodical approach that should include the acquisition of data at pivotal process steps, rigorous data analysis, easy access, and controlled storage and dissemination of information about the product, process, and components. All desired or necessary activities should be included, for example:
有效果且有效率的获取和分析工艺相关信息对于工艺理解和验证是非常重要。可以支持工艺验证的信息应进行识别、分析、交流、保留并可获得。很重要的一点是需要意识到，知识管理不仅是数据采集。这是一种具有策略性、系统性以及有序性的方法，应包括在关键工艺步骤数据的采集、严谨的数据分析、容易获得以及产品、工艺和组方有关信息的受控保存和传发。所有要求的或必要的活动均应包括在内，例如：
· Technology transfers
技术转移
· Process understanding
工艺理解
· Product characterization
产品特性
Knowledge management includes systems that capture review and feedback information in an effort to ensure correct decisions were made, and identify where process improvements can be implemented. Sources of knowledge include, but are not limited to:
知识管理包括了能捕获回顾和反馈性信息的各种系统，来努力保证决策的正确性，并可以识别出在哪些方面能够实现工艺改进。知识源包括但不限于：
· Prior knowledge (public domain or internally documented, such as similar processes)
已有知识（公开发表的文献或内部文件，例如类似工艺）
· Pharmaceutical development studies
药物开发研究
· Technology transfer activities
技术转移活动
· Process validation studies over the product lifecycle
产品生命周期内的工艺验证研究
· Manufacturing experience
生产经验
· Risk assessments
风险评估
· Continual improvement
持续性改进
· Change management activities
变更管理活动
The concept of sustainable and continually improved knowledge systems is essential to a lifecycle process validation program. The flow of information from Stage 1 Process Design to Stage 2 Process Qualification and back from Stage 3 Continued Process Verification form the basis of the lifecycle approach.
可持续性以及不断改进的知识系统的概念对生命周期工艺验证计划非常重要。基于生命周期方法，信息流从阶段 1 工艺设计到阶段 2 工艺确认，再返回到阶段 3 持续性工艺确证。
Knowledge management systems should be designed, installed, used, and maintained. They play a pivotal role in finding problems and preventing process shifts by providing feedback for continuous improvement efforts (4).
知识管理系统应进行设计、建立、使用并进行维护。这些系统可对持续性改进工作提供反馈信息，在发现问题以及避免工艺漂移方面扮演着非常关键的角色（ 4）。
Appropriate information must be acquired, used, and archived. It should be accurate, timely, and useful. Information should also be properly interpreted and effectively communicated.
适宜的信息必须进行采集、使用并存档。信息应为精确的、及时的并且是有用的。信息也应做以适当的解释并进行有效的交流。
Information or knowledge is gained in Stages 2 and 3 that can improve the process should be communicated back to those responsible for process design and development. The information (including responsible individuals, sampling plans, and justification) should be communicated via an appropriate tool.
在阶段 2 和 3 期间获得的可改进工艺的信息或知识应反馈回给负责工艺设计和开发的负责人员。相关信息（包括责任人员、取样计划和理由）应采用适宜的工具进行沟通传达。
Information needed to support the process validation effort should also be communicated to those responsible for monitoring and providing feedback on commercial product manufacturing. A system should be in place to provide feedback to those responsible for process design and development, to confirm the accuracy of early process design assumptions, and to improve the process where possible.
需要用来给予工艺验证活动支持的信息也应与负责对商业产品生产监控和给予反馈的人员进行交流。该系统也应在适当情况下对负责工艺设计和研发的人员给予反馈，以此来确认早期工艺设计设想的精准程度，并在可能的情况下改进工艺。
When changes are made in Stages 2 and 3, they should be communicated to all affected parties in an efficient, accurate, and timely manner. Formal Change Control procedures are a recommended and required Quality System component (4).
阶段 2 和 3 出现的变更应与所有涉及的部门和人员进行交流，交流应是有效的、精确的并且是及时的。推荐应用正式的变更控制流程并需要有质量系统元素（ 4）。
Transparent interaction between teams collecting data, performing risk assessments, and transferring information is essential to the process validation effort. Joint reviews between teams responsible for process development, risk assessments, and data collection should be conducted throughout the lifecycle of the process. These reviews enable the effective transfer of information from scale-up through full-scale manufacturing batches, and help to ensure that the process operates in a reliable and predictable manner.
各团队之间在收集数据、执行风险评估以及传递信息这些方面的透明化互动对于工艺验证活动是非常重要的。在整个工艺生命周期期间，负责工艺研发、风险评估和数据采集的各团队之间应当进行节点审核。这些审核可以促进从放大到正常规模商业批次之间的信息的有效转移，并有助于确保生产工艺是在一种可靠的并是可预见的模式下进行操作。
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