No.1
Q：Can talk a bit more about what expertise the firm may need to do a robust risk assessment for sterile process?
能否就公司对无菌工艺进行可靠风险评估所需的专业知识多作一些介绍？
A：This was discussed on the webinar and there is a wide range of risk tools and assessments that can support QRM. The level of effort and formality should be commensurate with the level of risk. For core sterile processes, formal risk assessment is appropriate and some of the key considerations are outlined as follows:
已在网络研讨会上对此进行了讨论，并且有多种风险工具和评估方法可支持质量风险管理（QRM）。工作量水平和正规性应与风险等级一致。对于核心无菌工艺，适宜进行正式的风险评估，一些关键考虑因素概述如下：
- Qualified risk facilitator: someone who understands QRM and the risk tools and can facilitate formal risk assessments
- 有资质风险协调者：熟悉质量风险管理（QRM）和风险工具并可协调正式风险评估的人员
- Strong process knowledge
- 扎实的工艺知识
- Cross functional team of appropriately qualified/experienced SMEs and an independent person who is less familiar with the process
- 由具有相应资质/经验的主题专家（SME）组成的跨职能团队，以及对工艺不太熟悉的独立人士
- A clearly defined risk question and scope and an appropriate process flow to guide and structure the risk assessment
- 明确定义的风险问题和范围以及恰当的工艺流程，以指导和构建风险评估
- Pre-defined rating and assessment criteria
- 预定义的评级和评估标准
- A walkdown of the area/visual review of the process and flows
- 区域巡查/工艺和流程的目视检查
No.2
Q：What's the relationship between the Risk Assessment and CCS? Which one should be the first step?
风险评估与污染控制策略（CCS）有什么关系？应采用哪一项作为第一步？
A：The CCS is a holistic term covering all aspects of your control strategy to manage and reduce the risk of contamination. This includes the overall evaluation of risk and the outcomes from the supporting risk assessments and justifications.
污染控制策略（CCS）是一个全面性术语，涵盖控制策略的各个方面，旨在管理和减少污染风险。这包括对风险的整体性评价以及支持性风险评估的结果和合理性说明。
The sequence depends on where you are in your lifecycle. If you are at the start of the lifecycle you might start with outlining your CCS plan; Your intent to proactively manage contamination control with integrated use of QRM and the key milestones to deliver that control.
其顺序取决于在生命周期中的哪个阶段。如果正处于生命周期的开始阶段，则可首先概述污染控制策略（CCS）计划；目的是通过综合使用质量风险管理（QRM）和实施该控制措施的关键里程碑，主动管理污染控制。
If you are already well established you might have performed risk assessments as part of your existing PQS. Your gap assessment would then inform your CCS. The CCS would summarise the controls you have in place, feedback from the listening systems and living risk assessments to provide an evaluation of the risk profile and the plans for CAPAs or continuous improvement to further augment controls.
如果您已建立良好的控制措施，则可能已作为现有制药质量体系（PQS）的一部分进行了风险评估。然后，差距评估将向污染控制策略（CCS）发出通知。污染控制策略（CCS）会汇总已有的控制措施，了解系统的反馈意见和微生物风险评估，以评估风险状况和纠正与预防措施（CAPA）计划或持续改进以进一步增强控制措施。
No.3
Q：Two terminal filters in series are tested separately or in series?
两个串联的终端过滤器是单独测试还是串联测试？
A：With regard to post use integrity testing; testing should be performed prior to removal of the filter from its housing. If the sterilizing system is validated with multiple filters, then all filters must pass post use FIT.
关于使用后完整性测试；应在将过滤器从其外壳拆下之前进行测试。如果消毒系统已通过了多个过滤器验证，则所有过滤器必须通过使用后过滤器完整性测试（FIT）。
No.4
Q：If the sterilizing filtration process has been validated as a system consisting of multiple filters to achieve the sterility for a given fluid, the filtration system is considered to be a single sterilizing unit and all filters within the system should satisfactorily pass integrity testing after use.
如果除菌过滤工艺经过验证，作为一个由多个过滤器组成以满足给定液体无菌要求的系统，那么这个系统认为是一个单一除菌单元，并且系统内所有的过滤器都应在使用后令人满意地通过完整性测试。
A：If the system is validated as a single filter with a redundant filter present the primary sterilizing filter must pass FIT. If it does not, a risk assessment is required to determine the acceptability of performing a FIT on the redundant filter.
如果系统经过验证，除了第一个过滤器，还有第二个（冗余）过滤器，则主要灭菌过滤器必须通过过滤器完整性测试（FIT）。如果未经过验证，则需要进行风险评估以确定对冗余过滤器执行过滤器完整性测试（FIT）的可接受性。
Such a risk assessment is likely to be accepted if the first filter was pre-use tested separately, but would be difficult to defend if the filter was tested as part of the pre-use testing of the second filter.
如果对第一个过滤器进行单独的使用前测试，则可能接受这种风险评估，但是如果将该过滤器作为第二个过滤器的使用前测试的一部分进行测试，则可能无法接受。
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