Visual inspection of injectables has become one of the most
dynamic functions in pharmaceutical manufacturing. Advances
in technology have given us a remarkable ability to assess the
contents of individual parenteral units with increasing sensitivity.
Noninvasive technology allows us to confirm the adequacy
of container closure. Enhanced orthogonal tools and techniques
permit a better understanding of the characteristics of both inherent
and extraneous materials.
But significant challenges persist. Difficult-to-inspect products,
such as suspensions, lyophilized cakes, opaque containers, large
volume parenteral flex bags and blow-fill-seal containers add
significant complexity to visual inspection process design and
qualification. Likewise, the increasing development of complex
biotherapeutics introduces the need for added discrimination
between acceptable inherent proteinaceous drug product and
undesirable extraneous matter through enhanced noninvasive
inspection techniques. In addition, all of this results in updated
regulatory and compendial requirements.
Staying attuned to the changes in regulatory and compendial requirements,
inspection process capability, advances in inspectionrelated
technology and the impact on the ultimate recipient—the
patient—is essential to address the question: Are our visual inspection
programs built to meet the litmus test of quality and capability?
The PDA Visual Inspection Forum provides an unparalleled opportunity
to participate in in-depth discussions of new technologies,
hear insights from regulators and engage with recognized leaders in
visual inspection. This year’s sessions include updates on regulatory
compendial issues, particle control and characterization and
difficult-to-inspect products, including biopharmaceutical inspection
and primary packaging material considerations—all augmented
with case studies and interactive Q&A opportunities. As in past
years, the meeting will feature an exhibition with multiple poster
presentations and vendor booths where attendees can see the latest
in commercial inspection hardware and discuss production needs
with key suppliers of inspection systems and services.
(Learn more about the 2017 PDA Visual Inspection Forum and related PDA Education courses.)