ECA Releases Version 5.0 of Visual Inspection Guide

The ECA Visual Inspection Group has released Version 5.0 of its guide, incorporating extensive updates and a new chapter on inspecting difficult-to-inspect units. The document also provides detailed procedures for handling particles detected during the AQL test. It will be presented and distributed at the ECA Visual Inspection Group Conference on 22–23 October 2025 in Vienna.

Key updates in Version 5.0 include:

• Chapter 5 on inspecting challenging items, such as lyophilized products, bags, and opaque solutions
• Refined guidance on functional test kits in routine inspections
• Updated sections on requalification and revalidation of automated inspection systems
• Expanded procedures for particle detection during AQL testing
• Regulatory updates, editorial refinements, and revised batch release guidance
• Additional definitions, including PQ and PV

The guide aligns with EU GMP Annex 1, USP <790>/<1790>, Ph. Eur. 2.9.20 & 5.17.2, and the FDA Draft Guidance on Visible Particulates. All conference participants will receive the updated version free of charge.

13-10-2025