483表格:分析仪器校准_仪器仪表_资讯

483表格:分析仪器校准

2024-01-14 08:42 浏览:27

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA regularly publishes some of these reports under "Frequently requested or proactively posted compliance records" on the FDA homepage.

FDA检查员在检查期间的观察结果列在483表格上。FDA定期在其网站主页下的“经常要求或主动发布合规记录”页面发布其中的一些报告。

On 29 November, a new FDA Form 483 that goes back to an inspection from 19 to 27 October 2023 at Dr. Reddy's Laboratories Ltd. in India was published. The 23-page report lists a total of 10 observations.

11月29日，FDA向印度的Dr. Reddy's Laboratories Ltd.发布了一份新的483表格，该表格可追溯到2023年10月19日至27日的检查。这份23页的表格共列出了10项观察项。

Analytical Instruments 分析仪器

One of the observations described in thereport is related to laboratory instruments, apparatus and recording devices. The FDA investigator writes that "major laboratory equipment including but not limited to HPLCs, GCs, and UV Spectrophotometers that are actively used in commercial release and stability analysis were observed not meeting the calibration specifications." The report describes several examples in detail.

表格中所述的一项观察项与实验室仪器、设备和记录装置有关。FDA调查员写道:“主要的实验室设备，包括但不限于在商业放行和稳定性分析中经常使用的高效液相色谱、气相色谱和紫外分光光度计，被观察到不符合校准规范。”报告详细描述了几个例子。

Furthermore, the authority criticizes the firm's SOP on "Management of Laboratory Equipment and Instrument". The FDA Form 483 states that this SOP"requires preventive maintenance be done on the equipment prior to routine calibration. During preventive maintenance (PM), potentially the equipment is opened apart and parts are changed as needed. After PM the equipment calibration is performed. However, by this practice the equipment is potentially altered just before the calibration and a conclusive assessment can not be made if the equipment was performing accurately and precisely during the entire calibration cycle."

此外，FDA还批评了该公司关于“实验室设备和仪器管理”的SOP。表格指出，该SOP“要求在常规校准之前对设备进行预防性维护。在预防性维护(PM)期间，可能会拆开设备并根据需要更换部件。PM后进行设备校准。然而，通过这种做法，设备可能会在校准之前发生变化，并且如果设备在整个校准周期中准确无误地运行，则无法下达总结性的评估结论。”

Furthermore,"appropriate controls were not exercised over the Laboratory Information Management System (LabWare LIMS) that changes are instituted only by authorized personnel." For example, samples and tests in LIMS were cancelled without adequate controls in place and LIMS samples were created without justification and entries were not reviewed.

此外，“没有对实验室信息管理系统(LabWare LIMS)进行适当的控制，只有经过授权的人员才能进行更改。”例如，在没有适当控制的情况下取消了LIMS中的样品和测试，在没有理由的情况下创建了LIMS样品，并且没有审核系统中的数据。

Further Observations 更多观察项

The form also lists a number of other deviations, related to the following:

该表格还列出了一些与以下其他的偏差：

Major production equipment was not appropriately cleaned and maintained to prevent contamination.

主要生产设备未进行适当的清洁和维护，以防止污染。

The responsibilities and procedures were not fully followed. There was a lack of adequate evaluation of equipment conditions upon preventative maintenance, equipment cleaning, and line clearance.

职责和程序没有完全遵守。在预防性维护、设备清洁和生产线清场方面缺乏对设备状况的充分评估。

The determination of conformance to written specifications were deficient for TAMC (Total Aerobic Microbial Count) test and TYMC (Total Yeast and Mold Count) test conducted for purified water and drug products.

对纯化水和药品进行的总需氧微生物(TAMC)检测和总酵母和霉菌(TYMC)检测的符合性判定标准存在缺陷。

The quality unit failed to investigate deviations and investigations as well as consumer complaintsthoroughly.

质量部门未能彻底调查偏差、调查以及消费者投诉。

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.

检测方法的准确性、灵敏度、特异性和可重复性尚未建立。

Core processing areas were not maintained adequately to prevent mix up and or contamination.

核心加工区域没有得到充分的维护，以防止混淆和/或污染。

The firm failed to establish and/or follow adequate written gowning procedures pertaining to the core manufacturing areas.

公司未能建立和/或遵循与核心生产区域有关的充分的书面更衣程序。

中文翻译来自公众号：Pharma之路。

原文来自ECA网站，点击“阅读原文”可以查看原文。

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