Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication

FDA is working with industry, academia, and other regulators globally on major information management initiatives intended to help industry and regulators communicate about pharmaceutical excipients and fill gaps in existing regulatory database efforts, such as the agency’s Inactive Ingredients Database (IID).

While a collaboration between FDA and the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) on the agency’s IID has been fruitful (IPQ December 3, 2013), the accuracy and content challenges that remain point to the need to develop a more in-depth and global approach to help resolve them.

The advancing projects that FDA is participating in include:

● a “Global Ingredient Archive System” (GInAS), being developed with broad international participation, that would identify, organize, and catalogue all pharmaceutical ingredients in line with ISO standard 11238 on the identification of medicinal products (IDMP)

● a “spectral library,” with USP participation, aimed at creating a more coherent approach for authentication of materials, including APIs, glass, poisons, packaging materials, and excipients.  The library will contain “fingerprint” spectra of confirmed materials that can be used for comparison with pharma company testing results (IPQ December 20, 2012). And,

● an “Excipients Knowledge Base,” spearheaded by the academic consortium, the National Institute for Pharmaceutical Technology and Education (NIPTE), that is focused on cataloguing and comparing excipient properties.

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