【讨论】How to reduce testing and comply with GMP?

清歌一曲月如霜

【讨论】How to reduce testing and comply with GMP?  


How to reduce testing and comply with GMP?

Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the materials are released only after their quality was judged as satisfactory.
But how to reduce testing and comply with GMP?
According to the revised draft chapter 5 – Production – of the EU GMP Guide from January 2013, the selection, qualification, approval and maintenance of suppliers has to be documented and the level of control has to be proportionate to the potential risks posed by the individual materials. Manufacturers of medicinal products are responsible for testing the starting and packaging materials as described in the marketing authorisation dossier. However, it is explicitly accepted to utilise partial or full test analysis results for a material from an approved manufacturer, if the following requirements are fulfilled:
a) A formal agreement including the transport conditions to ensure the maintenance of the quality characteristics of the starting materials
b) Regularly performed audits at the production sites
c) A certificate of analysis signed by a designated person with appropriate qualifications and experience
d) Significant experience in dealing with the starting material manufacturer (“history of compliance”)
e) Full analyses that are performed regularly by the medicinal product manufacturer to compare the results with the supplier’s certificate of analysis.
The deadline for comments to the revised EU GMP Guide Chapter 5 was 18 July 2013. The deadline for coming into
operation will be 6 months after the publication of the final chapter 6.

清歌一曲月如霜

如何降低测试和符合GMP？

活性药物成分，赋形剂和包装材料的测试是在制药工业中的质量控制单元的主要任务之一。必须确保必要的测试均在进货，该材料仅被释放后，其质量是令人满意的判断。
但是，如何降低测试和符合GMP？
根据修订草案第5章 - 生产 - 欧盟GMP指南“从2013年1月，供应商的选择，资质，审批和维护必须记录的控制水平相称的个人所带来的潜在风险材料。医药产品的制造商是负责上市许可档案中所描述的用于测试的起始和包装材料的。然而，它明确接受经批准的制造商从材料利用部分或全部的测试分析结果，如果满足以下要求：
a）一个正式的协议，包括运输条件，以确保原料的质量特性的维护
二）定期进行审计生产基地
三）适当的资历和经验，分析证书由指定的人签署
四）重要起始原料制造商经验，在处理（遵守“历史”）
五）药用产品制造商定期进行分析的结果进行比较分析与供应商的证书。
修订欧盟GMP指南第5章的意见的截止日期为2013年7月18日。进入截止日期为
操作将在6个月后出版的最后一章6。

玻璃杯

软件翻译的不给力，但意思明白了

玻璃杯

感谢楼主分享，很多好资料，咱

yedonghua

看来我英语能力还有待提高啊

zdlxcb

谢谢楼主分享，个人认为如果原辅料和包材供应商以及自己公司质量管理体系已经很完善，那么采用上述减少项目检测还是可以接受的，对于一般的中小公司可能起到相反的效果。

青翼蝠王

感谢楼主分享，

alla110616

good informaiton and thanks for sharing