Stability post-licensure: compatibility container content - a practical case study.
Numerous variations to a manufacturing process may take place during the life cycle of a vaccine. To support these variations, the regulator requires providing stability data according to the existing ICH guidelines; these have been designed for documenting the licence of a new vaccine. Comparative studies and adapted stability designs specific to the variation will give far more confidence to the manufacturer and the regulator than the classical model. The following case study applied to a change of a stopper illustrates this approach.
Duchêne
M
M
GSK Biologicals, Belgium. michel.duchene@gskbio.com
Jeanmart
L
L
Slegers
B
B
D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods*; D004349:Drug Packaging / Q000331:legislation & jurisprudence / Q000379:methods*; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D008009:Licensure, Pharmacy; D012107:Research Design; D014612:Vaccines / Q000493:pharmacokinetics* / Q000592:standards / Q000600:supply & distribution
D014612:Vaccines