Critical Utilities GMP Compliance and new Annex 1

The issues exposed in this article were discussed in “Risk Based approach to Qualification Activities” Webinar by PQE, on April 20^th. Register to watch it on-demand (coming soon).

New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.