PDA Letter Article

PDA Visual Inspection Forum Returns; Lands in Berlin in 2022

by John Shabushnig, PhD, Insight Pharma Consulting LLC, and Romain Veillon, PharmD, GSK Vaccines

On behalf of PDA Europe and the program planning committee, we want to welcome you to the 2022 PDA Visual Inspection Forum. We have been hard at work organizing another conference to keep you current with advances in inspection technology and the ever-changing regulatory landscape. We are also excited to return to a live, in-person meeting format!

Visual inspection, and especially the detection of particles, remains at the center of many discussions regarding product manufacturing control, quality assurance and regulatory compliance. From 2017 to 2021, 33% of all injectable product recalls in the United States were associated with visible particulate matter, second only to sterility assurance. Particle-related recalls reached a high of 25 in 2014. While the number of recalls and FDA-483 observations have decreased significantly since this peak, visible particles remain of great concern. The long-awaited draft revision to the EU GMP Annex 1 guideline has been published and is expected to be issued in final form very soon. The brief chapters on leak testing and visual inspection in the current version have been significantly expanded with revised text containing several new expectations. “USP <1790> Visual Inspection of Injections” has also undergone a recent revision.

The Visual Inspection Forum, April 26-27, 2022 in Berlin, is the right event to discuss these recent regulatory changes. Further discussion is needed to better understand and implement the changes to Annex 1 and USP <1790>.

Visual inspection methods and technology also continue to advance. The application of enhanced detection methods such as artificial intelligence and deep learning to automated inspection is an exciting area of recent investigation. Early experience with these new tools suggests potential improvements in inspection sensitivity and a better avoidance of false rejection of good product. This, along with quicker methods or recipe development, should make this an important area for discussion and new learning. We will have experts working in the new field speaking at this year’s forum to share their practical experiences.

Since 2000, the Visual Inspection Forum has been organized to discuss new technical and regulatory developments in the field. We are pleased to have experts to discuss such new developments as a basic understanding of inspection process, special requirements for difficult-to-inspect products, particle characterization and safety implications, practical aspects of manual and automated methods and regulatory and compendial requirements like those found in the update of Annex 1 or USP <1790>.

This is an excellent opportunity to gain experience in visual inspection and to discuss inspection challenges with the experts. We have provided time in the program for networking with the speakers and for discussion of your specific inspection challenges. The meeting will conclude with a roundtable discussion on topics of specific interest to those in attendance. As in past years, the meeting will feature an exhibition where attendees can see the latest in commercial inspection hardware and discuss production needs with key suppliers of inspection systems and services.

We are also pleased to again add two optional two-day training courses. The first course, “An Introduction to Manual Visual Inspection,” covers the basics of the inspection process and its application to injectable products. It will be a combination of lecture/discussion and hands-on laboratory exercises used to develop and practice practical inspection skills. The skills developed through this course may be applied to both manual human inspection and automated machine inspection. The second course, “Mastering Automated Visual Inspection,” presents a comprehensive introduction into the specific need for automated visual inspection as a combination of lecture/discussion and hands-on training. Both courses will be held on 28-29 April, immediately following the Visual Inspection Forum and in the same location.

For more information on the Visual Inspection Forum and related Training and Research Institute courses, visit the event page.

We look forward to seeing you at this exciting and informative meeting!

About the Author

Romain VeillonRomain Veillon is Director Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites. For the past 22 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines, in support to production and secondary operations projects for filling and freeze-drying.

In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe. Since 2019, Romain co-lead task force to prepare a point to consider document for AI applied to Visual Inspection. In 2020 Romain received PDA James P. Agalloco Award for educational training.

John ShabushnigJohn Shabushnig, PhD, is the founder of Insight Pharma Consulting, which provides expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and nonsterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations.

John is an active member of the Parenteral Drug Association, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and leads the Visual Inspection Interest Group and also instructs at PDA‘s Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel.