Visual Inspection Group issues Version 5.0 of Guide

The Good Practice Guide "Visual Inspections of Parenterals" was originally developed by the advisory board of the ECA Visual Inspection Group. Much rather than a strict requirement document, this guide is intended to be a reference for controversial issues. A regular update of the guide is intended to keep it up to date.

The fourth edition was reviewed - and has been replaced by version 5.0. This new version introduces several significant updates, 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

This comprehensive revision aligns the Guide with the latest 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 Eur. 2.9.20 and 5.17.2, as well as the FDA Draft Guidance on visual inspection.

To download version 5.0 of the Guide, please visit the members' araa of the Visual Inspection Group website. And if you are not a member yet, sign up for membership  - it is free of charge.