New VDI Guideline 6022, Blatt 1.1 published as Draft
Recommendation
Thursday, 12 February 2026 9 .00 - 17.00 h
Best Practice for Manual and Automated Visual Inspection of Parenterals
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
In June, the VDI published the new guideline 6022 Blatt 1.1 as a draft for comment. The new document is intended to expand on the existing Guideline 6022 Blatt 1, which describes the overall hygiene assessment of ventilation and air-conditioning systems.
The new Blatt 1.1 concretises the requirements of VDI 6022 Blatt 1 with regard to decentralised air handling systems and units with or without fresh air connection (e.g. PIFFs - Plenum Integrated Filter Fan Units).
There was already a guideline of the same name, VDI 6022 Blatt 1.1:2012-08, which described how to create an inspection certificate according to VDI 6022 Part 1. However, this has been withdrawn and integrated into VDI 6022 Blatt 1. The same procedure is planned with Blatt 1.1, which is now published as a draft, i.e. direct publication as a whiteprint after the comment or objection process.
The draft of VDI Guideline 6022 Blatt 1.1 is available from Beuth Verlag.
Related GMP News
04.02.2026Endotoxins Testing: Potential Change for WFI and Steam in the USP
04.02.2026Microbiological Deviations and Technical Deficiencies - Warning Letter to US Manufacturer
28.01.2026Changes to the 'Water Monographs' in the European Pharmacopoeia
21.01.2026Deficient Water System: Warning Letter to US Manufacturer
17.12.2025FDA publishes new Draft Guideline on GMP for Medical Gases
10.12.2025VDI 6022 Sheet 8.1 published: Qualification for the cleaning of air-conditioning systems