This paper describes IPEC’s position on the relevance of data integrity guidance documents to the manufacture and supply of excipients.
Information Package User Guide and Template (EIP) (Version 4, 2020). The guide was originally published in 2005, and subsequently revised in 2009 and 2013 and is widely used globally.
Nitrosamines are classified as probable human carcinogens, suggesting that long-term exposure above certain levels may increase cancer risk for those exposed.
A nitrosamines template is now available for use in addressing queries.
Position paper on the Comparison of Pharmaceutical Excipients, Non-Dietary Ingredients in Dietary Supplements, Food Additives and GRAS Substances.