由于对数据完整性担忧，加拿大卫生部要求暂时隔离所有使用浙江海正药业有限公司API..

beiwei5du

Health Canada requests quarantine of drugs linked to Zhejiang Hisun Pharma due to data integrity concerns
由于对数据完整性担忧，加拿大卫生部要求暂时隔离所有使用浙江海正药业有限公司API的药品

Starting date:June 16, 2015
Posting date:June 16, 2015
Type of communication:Information Update
Subcategory: Drugs
Source of recall:Health Canada
Issue:Important Safety Information, New safety information
Audience:General Public
Identification number:RA-53817

Issue

Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Zhejiang Hisun Pharma Company Ltd., in Zhejiang, China, due to data integrity concerns.

Health Canada is taking this interim precautionary measure to help mitigate any potential risk in light of recent findings from a trusted regulatory partner that raised concerns about the reliability of the laboratory data generated at this site.

At this time there is no identified risk to health, and Health Canada is not requesting a recall of any products with API from Zhejiang Hisun Pharma currently on the Canadian market.

APIs are used to make finished drug products that are sold to consumers. A quarantine will mean that Canadian importers and distributors will stop distributing products in Canada with APIs linked to this site.

Health Canada continues to review information from the trusted regulatory partner and from Canadian importers. Canadians will be updated about a list of products affected by the requested quarantine through updates on the Inspection Tracker.

Canadians should not make any changes to their medication without first consulting with a healthcare professional.

Health Canada will continue to work with international partners and Canadian importers to gather and assess information regarding the situation and take action as necessary to help protect Canadians.

Health Canada will also engage the provinces and territories to share information about the situation.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866 225-0709

yuansoul

你不是学计算机专业的吧?

data integrity = 自圆其说

data integrity concerns = 无法自圆其说

阿门

石头968

数据完整性，又一道商业性门槛

yuansoul

石头968 发表于 2015-6-22 11:19
数据完整性，又一道商业性门槛

下一步就是门楼

石头968

yuansoul 发表于 2015-6-22 11:21
下一步就是门楼

下一步应该是刷指纹进入

yuansoul

石头968 发表于 2015-6-22 11:22
下一步应该是刷指纹进入

刷指纹识别不如 养殖比格犬识别有效性更好。指纹可以套膜。

syhorchid

倒霉的海正药业

石头968

yuansoul 发表于 2015-6-22 11:26
刷指纹识别不如 养殖比格犬识别有效性更好。指纹可以套膜。

也行吧，没养过

yuansoul

石头968 发表于 2015-6-22 12:03
也行吧，没养过

据说是 智商 很高的。

孙艳红

拿大卫生部要求暂时隔离所有使用浙江海正药业有限公司API的药品,由于对数据完整性担忧，使用过程出现质量问题？

hope_y8crE

因为实验室的数据完整性？

天上没有月亮

海正药业的人在哪里？快去联系斑竹，说这帖子严重损害了你们公司的利益，要求删铁啊

devoter2000

讨论有点跑题了

儍飞

天上没有月亮 发表于 2015-6-23 11:47
海正药业的人在哪里？快去联系斑竹，说这帖子严重损害了你们公司的利益，要求删铁啊

你也是海正的么

天上没有月亮

儍飞 发表于 2015-6-23 16:53
你也是海正的么

你猜不到的

yuansoul

“ @jordaniscz  智商高不如养海豚  发表于 4 分钟前” 洁净区进出口 可以 挖水池 或者 游泳池？ 海豚 需要 海水，这个饲养成本 太高了。

儍飞

天上没有月亮 发表于 2015-6-24 08:08
你猜不到的

嘿嘿嘿嘿嘿嘿嘿嘿

Mr.zhang

老外总有办法折腾咱们啊

沪上风云

海正还不错啊。。。。。。

苦瓜阿布

大家可以讨论一下电子数据完整性哦！
尤其是QC实验室的电子数据，电子图谱之类的数据，我们如何能保证正常生产过程中的数据完整性呢？