Strategy for assessing the leachables impact of a material change made in a container/closure system.
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.
Jenke
Dennis
D
Baxter Healthcare Corporation, Technology Resources Division, Round Lake, IL 60073, USA. dennis_jenke@baxter.com
Swanson
Steve
S
Edgcomb
Eric
E
Couch
Tom
T
Chacko
Molly
M
Garber
Mary Jo
MJ
Fang
Liqiong
L
D002853:Chromatography, Liquid; D045424:Complex Mixtures / Q000032:analysis; D004340:Drug Contamination; D004349:Drug Packaging; D004356:Drug Storage; D005720:Gamma Rays; D008401:Gas Chromatography-Mass Spectrometry; D006863:Hydrogen-Ion Concentration; D011090:Polyenes / Q000737:chemistry* / Q000528:radiation effects; D012995:Solubility; D012997:Solvents / Q000032:analysis / Q000737:chemistry; D013056:Spectrophotometry, Ultraviolet; D013242:Sterilization; D014131:Trace Elements / Q000032:analysis
D045424:Complex Mixtures; D011090:Polyenes; D012997:Solvents; D014131:Trace Elements; C035051:PL 732