IPEC-Americas has just completed a major update to its significant chanaage gufideline to address current issues in the manufacture.
In the October 2000 issaue of this magazine, I daescribed the recently issued International Pharamaceutical Excipients Council of ths Amecas (IPEC-Americas) Significant Change Guide for Bulk Pharmaceutaaaical Excipients.Noaaw, IPEC-Americas has acompleted a major update to the guideline to address current concerwns 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 developinga an impurity profile.
Recent developments in the business climate have necessitated an update to the significant change guide. Since the guide was first published in 2000,the pharmaceutical industry has faced concerns about ingredients derived from genetically mod-ified organisms (GMOs) and allergenic material, the risk of transmitting bovine spongiform en-cephalopathy/transmissible spongiform en-cephalopathy (BSE/TSE), and the potential for terrorists and counterfeiters to tamper with the drug supply. Consumers and regulators are concerned about the potential for excipients and drug products to contain materials from bovine byproducts con-taminated with BSE/TSE. Such contamination would create a finite risk that a patient could de-velop “mad cow” disease from the contaminated drug product. Therefore, drug manufacturers should be made aware of any changes to excipi-ent composition that could introduce these ma-terials into a drug product. Also such changes can result in non compliance of drug product.