EU GGMP Annex 1 2022 and Pharmaceutical Cleanroom Classification - Consideration of the changes from EU GGMP Annex 1 2008

Abstract

Classification is an essential part of the qualification activities for pharmaceutical cleanrooms to confirm the effectiveness of the airborne contamination control system. A review of the classification requirements and principles associated with ISO 14644-1:2015 and Annex 1 2008 of the European Union Guide to Good Manufacturing Practice (GGMP) has previously been reported. As this version has now been superseded by the 2022 edition, review of the relevant updates has been completed to assess the impact of the classification process for a cleanroom used for aseptic processing. With some additions and text updates, many of the requirements and expectations for classification can be considered to remain effectively unchanged from the 2008 version. However, there are items of more significant change for consideration and this article summarises those elements that have minimal impact and focuses upon the significant changes and provides recommendations, and options, to ensure continued meaningful classification. Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1 2022