N Nyeli Aug 30, 2017 #1 Aug 30, 2017 #1 Anybody knows where do I find Validation requirements imposed by CFDA? Thanks.
planB Trusted Information Resource Aug 31, 2017 #2 Aug 31, 2017 #2 Nyeli, are you looking for any specific validation? Would the information provided on the CFDA website help? HTH, Gerhard
Nyeli, are you looking for any specific validation? Would the information provided on the CFDA website help? HTH, Gerhard
Ronen E Problem Solver Staff member Moderator Aug 31, 2017 #3 Aug 31, 2017 #3 planB said: Nyeli, are you looking for any specific validation? Would the information provided on the CFDA website help? HTH, Gerhard Click to expand... I don't think that there's any guidance in there for validation. Ronen.
planB said: Nyeli, are you looking for any specific validation? Would the information provided on the CFDA website help? HTH, Gerhard Click to expand... I don't think that there's any guidance in there for validation. Ronen.
N Nyeli Sep 5, 2017 #4 Sep 5, 2017 #4 yes, there is nothing much published with regard to validation.
Gamula Involved In Discussions Sep 7, 2017 #5 Sep 7, 2017 #5 Dear Nyeli, oh yes, there is not a lot. But I would like to ask you what kind of validation? There are numerous possibilities like sterilisation, packaging. etc. Best, J
Dear Nyeli, oh yes, there is not a lot. But I would like to ask you what kind of validation? There are numerous possibilities like sterilisation, packaging. etc. Best, J
N Nyeli Sep 7, 2017 #6 Sep 7, 2017 #6 Hello Gamula - I'm looking for process validation guidelines in general not specific to any process. Thanks.
Hello Gamula - I'm looking for process validation guidelines in general not specific to any process. Thanks.
Gamula Involved In Discussions Sep 20, 2017 #7 Sep 20, 2017 #7 This is way to general....risk class, sterilisation?, active or passive device? I mean, the validation depends quite a bit on the device itself. A general validation is wihtin the technical part and the section research data has a part calles product validation. I hope you will find the thing you search for! Best!:
This is way to general....risk class, sterilisation?, active or passive device? I mean, the validation depends quite a bit on the device itself. A general validation is wihtin the technical part and the section research data has a part calles product validation. I hope you will find the thing you search for! Best!:
Ajit Basrur Staff member Admin Sep 20, 2017 #8 Sep 20, 2017 #8 Nyeli said: Anybody knows where do I find Validation requirements imposed by CFDA? Thanks. Click to expand... I would suggest if you have a local source in China, tell them to approach the CFDA and they would be able to help out. The CFDA has the website in English and Chinese but the English site is not fully loaded with their guidance documents as Chinese.
Nyeli said: Anybody knows where do I find Validation requirements imposed by CFDA? Thanks. Click to expand... I would suggest if you have a local source in China, tell them to approach the CFDA and they would be able to help out. The CFDA has the website in English and Chinese but the English site is not fully loaded with their guidance documents as Chinese.
Gamula Involved In Discussions Sep 21, 2017 #9 Sep 21, 2017 #9 Sometimes, the google or bing translator is helpful in translating the chinese CFDA webiste. You can find some marginal data at least. But, a local source is almost mandatory for a relatively fast registration.
Sometimes, the google or bing translator is helpful in translating the chinese CFDA webiste. You can find some marginal data at least. But, a local source is almost mandatory for a relatively fast registration.