RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 360
OP 380
VO 59
IS 6
A1 Jenke, Dennis
A1 Swanson, Steve
A1 Edgcomb, Eric
A1 Couch, Tom
A1 Chacko, Molly
A1 Garber, Mary Jo
A1 Fang, Liqiong
YR 2005
UL http://journal.pda.org/content/59/6/360.abstract
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.