Frances DeGrazio

With most biologics in development taking injectable form, drug makers are increasingly exploring the use of prefillable syringe and self-injection systems for their administration; the adoption of QbD principles helps to ensure that components are engineered with stringent and specialized needs in mind.

When it comes to getting the best out of quality by design, timing is everything.

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.