Archivel Farma, a member of Catalonia.health, has announced the renewal of its GMP manufacturing certification, confirming compliance with the requirements of the new Annex 1 and Annex 2 to produce sterile, freeze-dried and biological products, in accordance with current European regulatory standards.
Comprehensive Facility Upgrade
The GMP certification renewal is the result of a comprehensive process to upgrade facilities, manufacturing processes, and contamination control systems. Key initiatives include the implementation of an oRABS system with integrated SAS peroxide for aseptic manufacturing, as well as the introduction of a new semi-automated fill & finish line, designed to strengthen operational robustness, process precision, and support the production of small and medium batches.
Strategic Transformation into a CDMO
All of this is part of the strategic commitment of Archivel Farma's investors to provide the company with the infrastructure and capabilities necessary to complete its transformation into a CDMO specialized in high-complexity projects. In this context, Archivel Farma has thanked its investors for their commitment, as well as the dedication, involvement, and expertise of its entire team, key factors in making this transformation possible.
Enhanced Service Capability
The transformation of Archivel Farma into a CDMO consolidates its ability to continue offering reliable, flexible services fully aligned with the highest pharmaceutical quality standards. The new GMP certification, together with the technological improvements implemented, positions the company to meet the needs of the pharmaceutical sector in sterile, freeze-dried and biological products, with a focus on projects that require a high degree of specialization and regulatory compliance.
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