The Program Planning Committee invites you to participate in the 2023 PDA Visual Inspection Forum! Visual inspection (VI) continues to be critical to the manufacture and delivery of high-quality injectable medicines. This forum provides a platform to present and discuss new developments and expectations in the field of VI. This year we have returned to an in-person meeting after the success of the live event in Berlin in 2022.
The regulatory and compendial environment continues to rapidly evolve with new or revised guidance published this year. FDA has published a draft of their Inspection of Injectable Products for Visible Particulates guidance for industry and USP and EMA have finalized updates to USP <1790> and Annex 1, respectively. These new requirements encourage further discussion of the correct understanding and implementation of VI within the pharmaceutical manufacturing supply chain and provide one of this year‘s hot topics.
Automated visual inspection (AVI) provides significant benefits when integrated into the manufacturing process. This is especially true for mass market products such as the recent expansion of COVID vaccine production. Technological advancements, like the use of AI in image analysis and inspection recipe development, can offer significant performance improvements for AVI. Such advancements and other practical case studies on AVI implementation are planned for the agenda in 2023.
As in previous years, manual inspection remains an important means of monitoring and controlling product quality and the most widely used method for visual inspection. It continues to be the pharmacopeial reference method and practical experience with this method will also be addressed. Discussion of the key elements of a basic inspection and sampling process along with special considerations for difficult to inspect parenteral (DIP) products such as lyophilized and biopharmaceutical products, and those in special packing types are planned.