This project is part of the regulatory transformation imposed by the new GMP Annex 1, going from 16 pages to 57 pages. It aims to deploy a global compliance plan at the pharmaceutical group site, by strengthening risk management, process control and monitoring of critical areas to ensure sterility.
2022 - 13 months
France
Health and life science
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.
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.
The customer requires full compliance with the new GMP Annex 1, involving a redesign of processes and comprehensive documentation. He expects the team to take a holistic approach that integrates risk management, contamination prevention, and strict facility control. The objective is to guarantee the sterility of the site while ensuring a smooth transition to the new standards. The project must demonstrate rigorous execution with a high rate of on-time delivery, while validating each action through analyses and comprehensive qualification reports.
Ensure full compliance with the new GMP regulations.
Strengthen controls and evaluations to prevent contamination.
Guarantee rigorous execution and complete monitoring of validated actions.
The mission is based on the implementation of a global strategy led by a team dedicated to compliance. It involves reorganizing internal processes to meet new regulatory requirements, based on thorough risk assessments and robust documentation. Key actions include managing 20 holistic risk assessments, 17 risk analyses and 56 change controls, thus ensuring optimized airlock transfer and the adequate classification of cleanrooms. The objective is to ensure the integrity of production practices and to minimize the risks of contamination.
Manage a change management strategy with follow-up and systematic control.
Conduct a series of analyses and evaluations to prevent the risks of contamination.
Establish specific guidelines on airbags, clothing and rinses.
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