The starting point for any successful adaptation to the updated GMP Annex 1 is to carry out a comprehensive GAP analysis. The aim is to identify deviations between the existing processes and the new regulatory requirements.
The revision of Annex 1 represents an increased emphasis on risk assessment and the introduction of a Contamination Control Strategy (CCS). The GAP analysis begins with a detailed assessment of all relevant areas, from sterile production to cleanroom design and operational processes.