About the Speakers
Visual Inspection of Difficult to Inspect Parenteral (DIP) Products: A Regulatory and Compendial Update and Review of Recent Guidance
Presented by: John Shabushnig
John Shabushnig is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He has worked for Pfizer, Pharmacia, Pharmacia and Upjohn and The Upjohn Company and held a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University.
John is an active member of the Parenteral Drug Association. He currently leads the Visual Inspection Interest Group and is an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection Expert Panel. He has published and presented numerous papers and is a co-author of the recently released book "Visual Inspection and Particulate Control."
Visual inspection (VI) is critical to the manufacture of injectable drugs. It may be performed with the human eye or automated camera-based systems. Many product formulations and packages limit the ability to detect particles and are thus considered difficult to inspect parenteral (DIP) products. Such products require additional test activities to demonstrate compliance with global cGMP expectations.
This talk will look at the recall history of injectable drugs and proposed changes to the regulations for VI in the US and EU. We will look at recent guidance for DIP products from the PDA and conclude with a look at new developments in inspection technology that may help address some of the challenges with these products.
Case Study - Visual Inspection Program Supporting Difficult To Inspect Products at a New Facility
Christian Phillips has worked in the life science industry for the last 25 years serving multiple roles focused primarily on the development, design, and implementation of sterile drug product GMP manufacturing processes and quality systems. Christian spent over ten years working at AMRI, a CMO specializing in the clinical/commercial manufacture of parenterals. At AMRI Christian served lead roles as Head of Process Engineering, Quality Assurance, and ultimately General Manager / Site Head for its Burlington, Mass. facility where he was exposed to dozens of pharma and biotech platform technologies spanning hundreds of products. Christian is currently the Sr. Director of Drug Product Development at Ra Pharmaceuticals.
This case study will chronicle the measures taken to develop and implement a comprehensive visual inspection program at a new facility that manufactures Difficult to Inspect parenteral drug products as defined in PDA Technical Report No. 79, with a focus on visible particulate defects. The challenges associated with the development, optimization, and qualification of a customized visual inspection procedure (i.e., differing from the compendial method) will be discussed. The presentation will include a detailed overview of the visual inspection program architecture supporting this procedure including a description of a lifecycle approach to establishing preliminary alert/action limits, defect trending as well as defect prevention/detection.