Strategy for assessing the leachables impact of a material change made in a container/closure system
Jenke, D.; Swanson, S.; Edgcomb, E.; Couch, T.; Chacko, M.; Garber, M.J.; Fang, L.
PDA Journal of Pharmaceutical Science and Technology 59(6): 360-380
2005
ISSN/ISBN: 1079-7440 PMID: 16471424 Document Number: 9952
Container/closure systems are extensively characterized in terms of their propensity to contribute leachable substances to the drug products they contain. Such a characterization is relevant until a change occurs in the composition or production of the container/closure system itself or the raw materials it is comprised of. When such a change occurs, it is necessary to ascertain the impact that the change would have on the validity and applicability of the previously performed leachables assessment. A general methodology for performing change control evaluations is developed in this manuscript and is illustrated via the use of a case study.
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