FDA质量体系成熟度十大标志！

在本月早些时候主办的cGMP会议上，FDA的合规部门鼓励制药公司保持'质量成熟度'，并具体说明FDA希望看到什么。会上几位FDA发言人讨论了拥有成熟质量体系的重要性，FDA负责中心战略规划的副主任特蕾莎·穆林（Theresa Mullin）提出了关于确保'质量成熟度'的适当步骤，具体如下（重点如下）：

1. Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.

   将优化的机制和清洁程序书面化作为最佳规范，并在整个工厂中推广。

2. A large percentage of equipment on the shop floor is currently under statistical process control. 

   车间的大部分设备均处于统计过程控制之下。

3. For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.

   对于根本原因分析，公司有标准化的工具，以便更深入地了解问题的影响因素。

4. Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.

   生产部门的目标与企业目标保持一致，工厂具有明确的重点。

5. Manufacturers have joint improvement programs with suppliers to increase performance.

   生产商与供应商联合制定改进计划，以提高性能。

6. All potential bottleneck machines are identified and supplied with additional spare parts.

   识别所有潜在的瓶颈机器，并配备额外的备件。

7. For product and process transfers between different units or sites, standardized procedures exist that ensure a fast, stable and complied [probably should read “compliant” instead of “complied”] knowledge transfer.

   具备标准化程序来管理不同部门或工厂之间的产品转移和工艺转移，以确保快速、稳定和合规的知识转移。

8. Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.

   在车间张贴显示当前性能状态的图表（如当前废品率），并且对所有人可见。

9. The firm regularly surveys customers’ requirements.

   公司定期调查客户的需求。

10. The firm ranks its suppliers and conducts supplier qualifications and audits.

    公司对其供应商进行排名，并进行供应商确认和审计。

会上提及FDA将会在工厂检查中更加注重质量成熟度，并将制定标准，以更一致地衡量检查期间观察到的质量成熟度状态！