lOn July 13, 2023, we observed Fentanyl 10mcg/ mL 100ml bags, lot (b)(4) with four different technicians' initials conducting the VI and labeling of (b)(4) over two different work shifts without specifying which technician conducted the activity. Furthermore, we observed over 20 units of finished product of lot (b)(4) left unlabeled with no indication as to whether the units have been visually inspected. In addition, per SOP-CAPS-4000688 Visual Inspection, operators are instructed to take (b)(4) breaks; however, there is no traceability for the visual inspection rest time of the technicians since your firm does not document time and operator specific times to include when a technician starts visual inspection, takes a lunch break, takes a (b)(4) visual inspection break, leaves the shift or starts the shift.
2023 年 7 月 13 日，我们观察到芬太尼 10 微克 / 毫升、100 毫升装的药袋，批号为（b）（4），有四位不同技术人员的姓名首字母标记，这些标记表明该药袋在两个不同的工作班次中进行了目视检查（VI）和贴标操作，但并未指明具体是哪位技术人员开展了这些活动。此外，我们还观察到，批号为（b）（4）的成品中有 20 多件未贴标签，且没有任何迹象表明这些成品是否已进行过目视检查。另外，根据标准操作规程 SOP-CAPS-4000688《目视检查》，操作人员被要求进行（b）（4）规定的休息；然而，对于技术人员的目视检查休息时间却无法追溯，因为贵公司并未记录具体时间以及操作人员的特定时间，其中包括技术人员开始目视检查的时间、午餐休息时间、进行（b）（4）规定的目视检查休息时间、下班时间或上班时间。

The post inspection recovery time for visual Inspection staff is of essential importance. The maximum time for continuous inspection activity between breaks and the total maximum inspection time for a shift/workday must be defined.
目视检查人员的检查后恢复时间至关重要。必须明确规定两次休息之间连续检查活动的最长时间和一个班次/工作日的总最长检查时间。

Industry practice is 20-60 minutes of inspection. A current good practice goal is 30 minutes of inspection followed by a break of at least 5 minutes continued for a total maximum duration goal of no longer than 4 hours. All Maximum uninterrupted inspection activity has to be qualified.
行业惯例是检查 20-60 分钟。目前的良好做法是检查 30 分钟，然后休息至少 5 分钟，总的最长持续时间是不超过 4 小时。所有最长的不间断检查活动都必须确认。