The evolution of Good Manufacturing Practices has led to a major overhaul of GMP Annex 1, which, by increasing from 16 pages and 123 chapters in 2009 to 57 pages and 294 chapters in 2022, imposes new regulatory requirements and thorough change management. In this context, the pharmaceutical group site must adapt its processes and installations. Consultys is committed to a global compliance plan based on four essential components: risk management, prevention of cross-contamination, process control and optimization of facilities to ensure global sterility.

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The approach includes conducting 20 holistic risk assessments, setting up more than 360 approved documents, and executing 73 qualification reports. Specific actions, such as the creation and qualification of transfer locks, the classification of cleanrooms for personnel and the establishment of a new directive concerning specific clothing, are also being deployed. In addition, an additional rinsing step ensures the absence of residues, and targeted environmental monitoring ensures air quality both during and outside manufacturing operations. Thanks to the full commitment of the team, 99% of the actions were delivered on time for the release of the annex in August 2023, with the remaining actions in line with the risk analysis.