European Non-Compliance Report on Da
欧洲关于数据完整性的不符合性报告
The results of inspections performedby the European authorities are published in the EudraGMDP database. Negativeresults can be found in the "Non-Compliance Reports" area - see ourNews "Already 13 EMA GMP Non-compliance Reports in 2016 published".
由欧盟药监实施的检查结果都公布在EUGMDP数据库中,负面结果可以在我们的新闻“不符合报告”中找到。
On 17 March.2016, theBritish authority MHRA published a Non Compliance Report against theIndian company Marksans Pharma Limited. The report lists serious problems withregard to da
在2016年3月17日,英国药监MHRA公布了关于印度公司MARKSANS药业的不符合性报告。报告中列出了关于数据完整性的严重问题。
A number of serious violations of thepharmaceutical quality system had already been observed during a firstinspection performed in March 2015. These violations related to the systemsassuring da
在2015年3月实施的首次检查中,已发现了其PQS有大量的严重违规情况。这些违规情况是关于确保数据完整性、偏差和CAPA管理、变更控制、PQR和自检方面的体系问题。在2015年11月再次检查中,检查员注意到许多违规行为并没有改善。其中,关于确保数据完整性系统的关键违规仍然存在:
· Evidenceof destruction of multiple parts of records of prime da
· 原始数据记录多个部分被销毁的证据
· OverallDa
· 全面数据完整性管理和监管
· Investigationsinto Missing and deleted da
· 对化验室里缺失和被删除数据的调查不完整
· Procedurescontrolling Da
· 化验室没有控制数据完整性的程序
As a consequence for the company,comprehensive measures have been imposed until the Non Compliance Report isworked out:
检查结论是不符合的话,将针对公司采取全面措施直至不符合性报告被改正:
· Withdrawalof previous GMP Certificate No. ...
· 撤销之前的GMP证书
· Nofurther marketing authorisation(s) should be approved naming the site asmanufacturer
· 凡将该场所作为生产商的上市许可将不再被批准
· Nofurther batches of medicinal products considered non-critical to public healthto be supplied to the market whilst this statement of non-compliance remains inforce
· 在不符合性报告仍有效期间,非关键用药不能销售至欧盟市场
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