A Descriptive Study of the Regulations of Leachable and Extractables of US, Europe and Canada

Leachables and extractables are one of the most important reasons for drug product quality deterioration and degradation. These components tend to migrate from the interior regions of the packaging material to the drug product by causing interactions, due to absorption or adsorption of the same on the Drug Product. The USFDA, EU and Health Canada laid down specific non-exhaustive regulation and guidelines that are to be followed in mandatory to attain drug approvals from these regulated regions. The USFDA, in its recent revision of its ANDA (Abbreviated New Drug Application) checklist, has included leachables and 3xtractables as an essential parameter of rejection of the ANDA application. The same agency recommends the applicant to take up leachables and extractables study during the developmental stages, to avoid further repercussions. The EU, on the other hand, suggests the regulations on the same leachables and extractables mainly for the plastic-based packaging containers, while mentioning the testing for glass-based containers. Canada has the least of the three in content regarding the leachables and extractables however, the same country respects a proper protocol in testing, threshold setting and its inclusion in final CTD submission in line with the laid regulations of the USFDA. The complete document describes the regulations of these three regions about leachables and extractables.