台湾Yung Shin Pharmaceutical Ind Co和英国SCM PHARMA LIMITED被欧盟警告

清歌一曲月如霜

不符合规定的性质：有一个缺乏控制的GMP湿热灭菌工艺，包括多孔循环设计，控制和验证和消毒就地管道和容器中的。不遵守的声明仅针对检查这些方面。复验须核实执行由该公司之前发布的GMP证书相应的建议措施。


不符合规定的性质：1，一个关键的缺陷被引用关于潜在产品的交叉污染，这方面的不足被分为两部分：A.潜在化学污染，人们发现，该公司是在制造一种有效的细胞毒性（安吖啶）产品非烈性套房。流程旨在包含产品已经失败，清洗过程和验证薄弱与可见一般制造业领域的污染。 B.潜在的微生物污染。有被污染了未充分调查和根本原因解释和缓解过程模拟媒体。的填充隔离VHP禁制充分控制和验证，并在环境监测计划的弱点。 2，关于变更控制程序（不是所有的变化适当地进行控制）和调查，这是质量差的问候根本原因分析和纠正措施和预防措施，并没有及时执行的重大缺陷。 3，关于维修设备和设施，控制不佳的第二个重大缺陷见证


Nature of non-compliance : There was a lack of GMP control of moist heat sterilisation processes, including porous cycle design, control and validation and sterilisation-in-place of pipework and vessels. The Statement of Non-Compliance is specific to these aspects of the inspection only. A reinspection will be required to verify implementation of appropriate proposed actions by the company prior to issuance of a GMP certificate.


Nature of non-compliance : 1.  A critical deficiency was cited regarding potential product cross contamination, this deficiency was divided into two sections : A. Potential chemical contamination, it was found that the company were manufacturing a potent cytotoxic (Amsacrine) product in the non-potent suite. Processes intended to contain the product had failed and cleaning process and verification were weak with contamination of general manufacturing areas seen. B. Potential microbial contamination. There were contaminated process media simulations that were not adequately investigated and root cause explained and mitigated. VHP sanitisation of the filling isolator inadequately controlled and validated and weaknesses in the environmental monitoring program. 2.  A major deficiency regarding the change control program (not all changes were controlled appropriately) and investigations, which were poor in quality with regards to root cause analysis and corrective and preventative actions and were not performed in a timely manner. 3.  A second major deficiency regarding maintenance of equipment and facilities with poor controls witnessed

冰城

不错的案例啊

幻影

楼主不生产帖子，楼主只是大自然的转帖工。

M.dufresne

我们一直致力于转贴事业三十年{:soso_e113:}

一沙一叶

帖子不全啊