PT  - JOURNAL ARTICLE
AU  - Dennis Jenke
AU  - Steve Swanson
AU  - Eric Edgcomb
AU  - Tom Couch
AU  - Molly Chacko
AU  - Mary Jo Garber
AU  - Liqiong Fang
TI  - Strategy for Assessing the Leachables Impact of a Material Change Made in a Container/Closure System
DP  - 2005 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 360--380
VI  - 59
IP  - 6
4099  - http://journal.pda.org/content/59/6/360.short
4100  - http://journal.pda.org/content/59/6/360.full
SO  - PDA J Pharm Sci Technol2005 Nov 01; 59
AB  - 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.