EU GMP Annex 1: The Impact On Pharmaceutical Cleaning And Disinfection

By Karen Rossington, Contec, Inc.

Cleaning and microbial contamination control are critical focus areas in pharmaceutical and medical device industry tries. Robust cleaning and disinfection programs are needed to meet the required cleanroom microbial grades, to prevent cross-contamination and subsequent microbial contamination of sterile medicinal products.

Learn about the current emphasis on separate cleaning and disinfecting steps, which reflects current best practices, and the most up to date re-write of the EU Annex 1. This document specifies guidance for the manufacturing of sterile medicinal products. A working group of 16 representatives, including The Pharmaceutical Inspection Cooperation Scheme, (PIC/S), WHO and EMA, the FDA, Japan, Australia, Canada, EDQM & ICH, a total of 52 authorities were involved in the project.