Understanding & Applying the updated FDA Guidance: Inspection of Injectable Products for Visible Particulate

Summary
Speakers

The presence of visible particulate in a parenteral product has the potential to cause patient harm. It is for that reason that parenteral products must be essentially free of visible particles, however achieving that goal can be challenging for drug product manufacturers. Particles can be introduced to the product at various points throughout the manufacturing process and can originate from extrinsic, intrinsic or inherent sources. The FDA is in the process of publishing a guidance titled “Inspection of Injectable Products for Visible Particulates” which focuses on a holistic risk-based approach for controlling the presence of visible particles beyond establishing a visual inspection program.

In this webinar we’ll review the details of the draft guidance as well as the importance of component selection as it relates to establishing a risk-based approach. We’ll also examine the role that the NovaPure^® product line can play in component selection including the importance of applying an appropriate test method for particle analysis of components.

Additionally we will discuss the newly published TR-85 “Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers“ and the role that it plays in testing components for visible particles.

John Rech

Technology Manager – Particle Testing

Mr. Rech has over twenty years of experience in the pharmaceutical industry including ten years of experience in the packaging and drug delivery industry. As a senior scientist, his areas of focus were centered around customer complaint and plant investigations as well as particle analysis. After several years in this role, he transitioned to the role of Technology Manager for Particle Testing, where he is currently leading method development and validation projects and is responsible for bringing new capabilities and technology into the West organization.

Ravi Patel

Director Quality Engineering & Metrology

Mr. Patel has worked within the pharmaceutical industry for over twenty years in various roles. Prior to joining West, he has held the post of chemist as part of research & development to design and synthesize small molecule heterocycles intended for treatment of specific RNA viruses and as an analytical chemist responsible for developing novel quantification methods for compounds as part of a team responsible for drug metabolism and pharmacokinetics assays. At West, he supported the microscopy team as a scientist within the quality organization for customer complaints and internal plant investigations, before transitioning to quality engineer responsible for validation and optimization projects. Prior to assuming the responsibilities as director of quality engineering and metrology, he also served as the manager of the customer complaints team for quality systems and for a short period project manager for quality operations. Ravi is currently responsible for global quality engineering projects, support of new metrology systems and their development, and various cross departmental projects.