TY - JOUR T1 - Strategy for Assessing the Leachables Impact of a Material Change Made in a Container/Closure System JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 360 LP - 380 VL - 59 IS - 6 AU - Dennis Jenke AU - Steve Swanson AU - Eric Edgcomb AU - Tom Couch AU - Molly Chacko AU - Mary Jo Garber AU - Liqiong Fang Y1 - 2005/11/01 UR - http://journal.pda.org/content/59/6/360.abstract N2 - 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. ER -