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The China Food & Drug Administration (CFDA) has released drafts of GMP Annex 1 Qualification and Validation and Annex 2 Computerized Systems for comment. You are receiving this message because you are a Member of one of the ISPE groups being invited to provide comments.
Please submit comments to ISPE by 17 July 2014 using the comment template provided below. Email the commenting form to regulatorycomments@ispe.org
- [url=]Annex 1[/url] | [url=]Annex 1 Comment Template[/url]
- [url=]Annex 2[/url] | [url=]Annex 2 Comment Template[/url]
For your convenience, the ISPE China Affiliate has provided translations of the documents; they are not the official English translations.
All comments received are vetted against the commenting guidelines by ISPE Member SMEs, the ISPE Regulatory and Compliance Committee, and ISPE Regulatory Advisors. Final comments are then sent to the regulatory body and posted on the ISPE website.
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