IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture.
In the October 2000 issue of this magazine, I described the recently issued International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) Significant Change Guide for Bulk Pharmaceutical Excipients.Now, IPEC-Americas has completed a major update to the guideline to address current concerns about bovine spongiform encephalopathy, genetically modified organisms, and allergens. The updated guide also contains a new section to assist manufacturers in developing an impurity profile. of excipient ingredients and to assist manufacturers in developing an impurity profile.




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