New Version 5.0 of the ECA Visual Inspection Guide for Parenterals

The ECA Visual Inspection Group has finalized the new Version 5.0 of its guide. The revision includes extensive editorial and content updates, as well as a new chapter on the inspection of difficult-to-inspect units and detailed guidance on the procedure to follow when particles are detected during the AQL test. The new document will be presented and distributed at the annual ECA Visual Inspection Group Conference, taking place on 22/23 October 2025 in Vienna.

The updated edition introduces several important additions and clarifications, including:

• A new chapter 5 on the inspection of difficult-to-inspect items (e.g. lyophilized products, bags, and opaque solutions)
• Refined guidance on the use of functional test kits in routine practice
• Updated sections on the requalification and revalidation of automatic inspection systems
• An expanded description of actions to take when particles are detected in the AQL test
• Regulatory updates in the trending chapter and other editorial refinements
• A revised batch release section aligned with the updated and new content
• Additional definitions, including PQ and PV

Version 5.0 reflects the current regulatory expectations from EU GMP Annex 1, USP <790>/<1790>, Ph. Eur. 2.9.20 and 5.17.2, as well as the FDA Draft Guidance “Inspection of Injectable Products for Visible Particulates.”

The new version will be presented during the ECA Conference “Visual Inspection of Parenterals,” taking place on 22/23 October 2025 in Vienna, and will be distributed free of charge to all participants.