FDA在印度药厂发现数据完整性违规行为

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FDA在印度药厂发现数据完整性违规行为

FDA警告信，日期为2019年5月4日，在检查人员发现该公司印度古吉拉特邦工厂的数据完整性偏差后，提交给Centurion实验室私人有限公司。在2018年10月22日至26日进行的检查中，检查人员发现对计算机系统缺乏控制，没有遵守设备清洁和维护程序。

具体来说，检查员在垃圾袋中发现了破损的文件，其中包括稳定性研究数据、分析测试表、分析计算和释放表格。检查人员能够从垃圾中删除一些文件，并发现数据显示了不规范的结果；然而，官方结果被记录在规格范围内。在记录试验数据之前，检查人员还发现了由质量单位准备、签署和批准的空白稳定性研究表格。FDA要求该公司向该机构提供纠正措施和预防措施计划。

据FDA称，该公司也未能确保只有授权人员对批量释放和稳定性测试设备进行更改。例如，质量控制分析师、公司高管和您的软件服务提供商都共享高性能色谱系统的用户名和密码。此外，分析人员还获得了系统管理员的全部权限。这些特权允许修改和删除数据文件和文件夹。此外，你缺乏一个程序来控制员工的使用和你的电脑系统的特权，“该机构说。

FDA建议该公司进行数据完整性补救，并提供详细的调查协议、对现任和前任雇员的访谈、对数据完整性缺陷的评估以及对测试数据的回顾性评估。

此外，根据这封信，该公司未能对分发给美国的药品进行风险评估，这些药品是在多用途设备上制造的，而这些设备没有经过适当的清洗。该机构要求该公司提供一项计划，以评估其清洁程序和验证研究，为其清洁验证战略提供科学依据，总结其清洁验证协议的更新情况，总结其核实和验证清洁程序的标准作业程序，并进行回顾性风险评估。

“在您完全纠正所有违规行为并确认您遵守CGMP之前，FDA可能会拒绝批准任何将贵公司列为药品制造商的新申请或补充剂，”FDA称。FDA于2019年3月11日发布了“进口警报66-40”。

DataIntegrity Violations Found at India Facility

PharmaceuticalTechnology

FDAsent a warning letter, dated May 4, 2019, to Centurion Laboratories PrivateLimited after inspectors found data integrity deviations at the company’sGujarat, India facility. During the inspection, which occurred Oct. 22–26,2018, inspectors found a lack of control over computer systems and a failure tofollow equipment cleaning and maintenance procedures.

Specifically,inspector found torn documents in trash bags that contained stability studydata, analytical testing sheets, analysis calculations, and release forms. Theinspector was able to remove some documents from the trash and found that thedata showed out-of-specification results; however, the official results wererecorded as within specification.  The inspectoralso found blank stability study forms that were prepared, signed, and approvedby the quality unit before test data were recorded. FDA asked the company toprovide a corrective actions and preventative actions plan to the agency.

Accordingto FDA, the company also failed to ensure that only authorized personnel madechanges to batch release and stability testing equipment. “For example, qualitycontrol analysts, a company executive, and your software service provider allshared a username and password for your high-performance chromatographysystems. In addition, analysts were authorized full system administratorprivileges. These privileges allowed modification and deletion of data filesand folders. Furthermore, you lacked a procedure for controlling staff use andprivileges of your computer systems,” the agency stated.

FDArecommended to the company that it perform data integrity remediation andprovide a detailed investigation protocol, interviews with current and formeremployees, an assessment of data integrity deficiencies, and a retrospectiveevaluation of testing data.

Inaddition, according to the letter, the company failed to perform a riskassessment of drugs distributed to the United States that were manufactured onmulti-use equipment that was not properly cleaned. The agency requested thecompany provide a plan to evaluate its cleaning procedures and validationstudies, a scientific rationale for its cleaning validation strategy, a summaryof updates to its cleaning validation protocol, a summary of its standardoperating procedures for verification and validation of cleaning procedures,and a retrospective risk assessment.

“Until you correct all violations completely and we confirm yourcompliance with CGMP, FDA may withhold approval of any new applications orsupplements listing your firm as a drug manufacturer,” the agency stated. FDAplaced the firm on Import Alert 66-40 on March 11, 2019.

Source:FDA

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