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Traditionally, FDA is organized into
centers that regulate specific types of products, but
the development of new products that merge different technologies
has blurred the once clear regulatory boundaries. Part
of the FDA definition of combination products reads, “A
product comprised of two or more regulated components,
i.e., drug/device, biologic/device, drug/biologic, or
drug/device/biologic, that are physically, chemically,
or otherwise combined or mixed and produced as a single
entity.” Because there was no regulatory scheme to
deal with this new technology, FDA established the Office
of Combination Products (OCP). One of its roles is to
develop guidance and regulations to clarify the regulation
of combination products.
Last fall, OCP issued a new draft guidance
document titled, “Current Good Manufacturing Practice
for Combination Products.” The guidance suggests
that because cGMPs and QSR are similar, developers of
combination products should be able to operate their manufacturing
facilities primarily using the quality systems already
in place. However, there are some key provisions in the
cGMPs that are not included in the QSR and need to be
considered in the manufacture of combination products
using a drug as one of the components. These include stability
testing, release testing for identity and strength of
active ingredients, and container/closure testing. In
addition, there may be some facility validation issues
presented by adding a drug or biologic to a medical device.
Combination products have been analyzed
in nearly every pharmaceutical department at Lancaster
Labs. “Stability testing expertise and our ability
to provide a highly trained workforce for large scale
projects in short time periods have attracted a number
of device manufacturers who are bringing combination products
to market,” says Greg Kupp, director of Pharmaceutical
Chemistry. “For stability projects, we can immediately
supply fully validated stability storage chambers with
environmental monitoring and a study tracking system.
Having these systems already in place allows our clients
to focus on the various other aspects of product development
and launch. In addition, we can use our knowledge of FDA
and ICH stability requirements to help clients with study
design and protocol creation,” notes Kupp.
Lancaster Labs also offers these other
testing services that are of interest to manufacturers
of combination products:
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