How to Qualify Container Closure Systems for Intended Use, Part 1
Kim, A.A.; Gehrmann, M.R.; McCaw, J.; McAndrew, T.P.
International Journal of Pharmaceutical Compounding 23(6): 454-461
2019
ISSN/ISBN: 1092-4221 PMID: 31751941 Document Number: 699380
The U.S. Food and Drug Administration regulates outsourcing facilities with the same stringency they apply towards drug manufacturers. This means that outsourcing facilities, who must navigate the changing regulatory landscape to achieve and maintain 503B status, need to focus on qualifying container closure systems for their intended use. Container closure systems must be fit-for-purpose (i.e., suitable for in-use conditions relative to drug product stability over intended shelf-life and storage conditions). This article, the first of a two-part series, addresses the critical aspect of how to qualify systems for intended use regarding container closure integrity. The second part will address component selection.