关于质量例会、变更控制、确认与验证的检查缺陷

关于质量例会

There was no written procedure for the Quality Monthly Meetings attended by the departmental managers to review the effective implementation of the quality system.

部门经理参加质量月度会议回顾质量体的有效实施没有书面规程.

The management team failed to ensure an effective implementation of the quality systems and to identify opportunities for continual improvement of components, processes and system itself.

管理团队未能确保质量体系的有效实施和确定组分、工艺和系统本身得以持续改善的机会

The outstanding quality items reported in the management review meetings were not challenged to identify the root cause for the delay. Risk assessments had not been performed or formally documented to assess the impact on patient safety and the effectiveness of the PQS as a result of choosing to delay addressing the overdue actions.

管理回顾会议中关于质量项目未解决的报告没有确定延迟的根本原因。推迟执行超期措施没有风险评估或书面文件来评估对病人安全的影响和质量体系的有效性。

The management review process was deficient, for example, the meeting minutes stated that all environmental monitoring results were satisfactory; despite there being an obvious adverse trend increase in clean room environmental monitoring results.

管理回顾程序是不充分的，例如，会议记录说到所有环境监测结果是令人满意的，除了洁净室环境监测结果有一个明显的不良趋势。

变更控制

There was insufficient detail recorded to describe the nature of the change and the actions to be carried out.

变更及需要执行的措施的描述记录不够详细。

There is no definition of which moderate level change controls would require a risk assessment and regulatory affairs review and which would not.

没有定义哪一级的变更需要风险评估以及法规事务的审核。

There is no post implementation review of the effectiveness of change control actions.

变更控制措施的有效性没有进行实施后的回顾。

Changes were implemented outside of the company’s Change Control procedure.

变更没有在公司的变更控制程序下实施。

Procedures for the prospective evaluation of planned changes and their approval prior to implementation taking into account regulatory notification were not robust.

预定变更及其批准的前瞻性评价程序在实施前对监管通知的考虑存在缺陷

There was no documented requirement for a post implementation effectiveness check to be performed.

没有书面要求进行实施有效性的检查

确认与验证

There was no change control or overall project plan in relation to the acquisition of the existing site, equipment and materials. There was no user requirement specification (URS) for the A facility, in contrast to the L facility.

现有设施、设备和物料的购置没有变更控制或总体项目计划，相比L设施，A设施没有用户需求规范（URS）。

The L facility URS was inaccurate, for example with regard to the number and capacity of manufacturing vessels.

在如关于生产容器的数量和容量方面L设施的URS有误。

The re-qualification of the L facility purified water system highlighted two potential action items during the installation and operation qualification reviews. These items were not addressed in the subsequent performance qualification exercise, and were not captured elsewhere in the PQS.

L设施纯化水系统的再确认在安装和运行确认审核期间强调了两个潜在的行动项目。这些项目没有在随后的性能确认中被解决，并且被排除在质量体系之外。

The Validation Master Plan did not cover all required high level aspects and validation of utilities, process validation and cleaning validation were not considered.

验证主计划没有包括所有要求的高水平的方面并且没有考虑公用设施、工艺验证和清洁验证。

There was no routine re-validation of manufacturing processes.

生产工艺没有日常的再验证

There was no cleaning validation for the non-dedicated sampling tools.

对非专用的取样工具没有进行清洁验证

The method used for isolator leak tests during validation and requalification would not detect leaks.

验证和再确认过程中用于隔离器泄漏率测试的方法不能检测到泄漏

Batch processing parameter ranges were not always supported by process validation data, for example the coating flow rate and the granulation chopper speed.

工艺验证数据无法支持批生产参数范围，例如，包衣风量和制粒切刀速度。

There is no clear indication in the process validation protocol that validation batches are predefined as potentially releasable for commercial sale.

工艺验证方案中没有迹象表明验证批次在放行至商业销售前得到确认。