These are updates from SFDA, China.
The update is in Chinese.
http://www.sfda.gov.cn/WS01/CL0050/72318.html
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Writing & Executing a Software Validation Protocol: Plain and Simple
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.
While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.
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Thread: SDFA --EXcipient updates
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07-05-2012, 07:33 AM #1Validation Guru
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SDFA --EXcipient updates
Durga Prasad
Internal Consultant,Aseptic Process-NNE Pharmaplan
www.nnepharmaplan.com
Denmark
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08-07-2012, 06:12 AM #2Validation Guru
- Join Date
- Oct 2010
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SFDA : Excipient guidelines
This latest guideline updated and released on 1st August 2012 is in Chinese.
http://www.sfda.gov.cn/WS01/CL0844/73959.htmlDurga Prasad
Internal Consultant,Aseptic Process-NNE Pharmaplan
www.nnepharmaplan.com
Denmark
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