I need to calculate an acceptance limits for topic formulation. Is it correct use 10 ppm criteria?
Basically, it is correct, but may rise some questions. I recommend you to have a look at the article “Setting Cleaning Validation Acceptance Limits for Topical Formulations”, published in the January 2 , 2008 issue of Pharmaceutical Technology:
http://pharmtech.findpharma.com/pharmtech/issue/issueDetail.jsp?id=13738
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Best regards
Alfred