Visual inspection of parenteral drug products is a critical aspect of pharmaceutical development and manufacturing, subject to evolving regulatory standards. This session brings together experts to address the complex landscape of particle visibility and regulatory compliance, with a focus on enhancing product quality and patient safety. The session will provide attendees with a holistic view of the challenges, innovations, and best practices in visual inspection, offering an overview of the regulatory and compendial environment for visual inspection.

Two of the talks will present new data on defining particle visibility: the results from a cross-industry visible particle threshold study, as well as the results from a stand-alone study exploring the opportunities for standardization based on common features of human visual perception.

The session also examines the unique challenges posed by visual inspection for Cell and Gene Therapy (CGT) products, considering whether there are regulatory gaps in this rapidly advancing field.

Finally, the critical role of regulatory agencies in ensuring the safety and efficacy of injectable pharmaceuticals will be discussed, highlighting the collaborative efforts between industry and regulatory bodies in addressing visible particulates in injectable products.

Session Speakers:

The Visual Inspection Regulatory and Compendial Environment: Current Issues and Opportunities
John Shabushnig, Insight Pharma Consulting

Regulatory Considerations for the Assessment of Visible Particulates in Injectable Pharmaceuticals
Rukman De Silva, CDER, FDA

From Blur to Clarity: Definition of Participle Visibility Threshold in Parenteral Drug Products

Felix Nikels, Boehringer Ingelheim Pharma GmbH & Co. KG

Atanas Koulov, Clear Solutions Laboratories

Visual Inspection and Particle Life Cycle Management for CGT Products - Same, Same, but Different... Are There Gaps in the Current Regulations?
Antonio Burazer, Takeda Austria GmbH

Additional Panelists:

Patricia Cash, Global Biotech Experts, LLC

Maryam Mazaheri, I-MAB Biopharma Co., Ltd.

Sophia Levitskaya-Seaman

Appearances