新的FDA警告信聚焦“数据完整性”

GMP News
08/09/2016

New Warning Letter of the FDA with the Focus on "Data Integrity"

新的FDA警告信聚焦“数据完整性”

Again, the focus of FDA's Warning Letter for the Chinese API manufacturer Zhejiang Medicine Co. Ltd. dated 4th August 2016 is on the lack of data integrity. Among other things, records of activities were made not at the time when they have been performed. Moreover, original data have been deleted. A number of alarming findings were discovered in the course of the FDA inspection in June 2015.

FDA于2016年8月4日对中国原料药生产商浙江医药发布警告信，又是缺乏数据完整性。除了其它问题，还有活动未在实施时记录。另外，原始数据也被删除了。在2015年6月FDA检查期间发现了大量的警示问题。

The FDA is now expecting concrete measures ("Data Integrity Remediation") from the company. For this, the FDA expressly recommended to retain qualified, external consultants. Among the measures to be taken:

FDA现在期望公司采取具体的措施（“数据完整性弥补措施”）。为此FDA表达了其聘请有资质的外部顾问的建议。期望其采取的措施有：

A - A comprehensive investigation of the extent of incorrect data
对不正确数据程度的全面调查报告
1. An extensive plan for the execution of the investigation
调查实施计划
2. Interviews of current and former employees to clarify the root cause of incorrect data
与现有和之前员工面谈以澄清不正确数据的根本原因
3. An assessment of the extent of data integrity deficits.
评估数据完整性缺陷的程度
4. A comprehensive retrospective assessment of the performance of analytical testing.
实施分析测试的全面回顾性评估

B - A current risk assessment of the possible effects of the deficiencies identified on the quality of the medicinal products, up to the risk to patients!

对药品质量中发现的缺陷可能对患者造成的影响进行风险评估

C - A management strategy for the implementation of CAPA plans.

CAPA计划实施管理策略

All in all, there were great concerns about the authenticity and reliability of the data produced in that company.

总而言之，在此公司产生的数据的真实性和可靠性让人极为担忧。

To find out more access the complete Warning Letter for Zhejiang Medicine Co. Ltd.

更多信息参见完整警告信。

来源：Julia

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