Review Of Annex 1 2022: Environmental Monitoring Changes

By Mark Hallworth, Senior GMP Scientis, Life Sciences, Particle Measuring Systems

In August 2022, a new revision of the EU GMP Annex 1 regulatory standard for sterile drug products was released, replacing the most recent draft from 2020 and the existing revision from 2008. These requirements regulate the manufacturing of sterile drugs made in and imported to the EU. Pharmaceutical manufacturing is performed in controlled environments to reduce contamination, and changes recently announced by Annex 1 focus more on strategic control than on measurement of quality. This new revision also better aligns the manufacturing principles contained in the Annex 1 to those presented by the World Health Organization (WHO), Pharmaceutical Inspection Cooperation Scheme (PIC/S), and US Food and Drug Administration (FDA).

The new revision is a complete rewrite of the existing Annex 1 from 2008 and almost quadruples the length. It divides the document into 10 newly defined sections. There is a new section that discusses the concept of contamination control strategy (CCS). This section shifts to a new paradigm of incorporating CCS as a central holistic approach to how each aspect of contamination interacts with the facility as a whole. There is also a new section that discusses and identifies Quality Risk Management (QRM) as a central principle to defining processes, operations, and limits, and it ties to CCS to balance process against risk. Additionally, as laid out in the new revision, regulations for Environmental Monitoring is essentially the same with a few enhanced descriptions to better align with QRM.