PDA Letter Article

Visual Inspection Faces Changing Environment

by John D. Ayres, MD, Eli Lilly and Company

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.

Visual Inspection

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.)