Archivel Farma renews GMP certification and strengthens its transformation into a CDMO
The GMP renewal is the result of a comprehensive process to upgrade the facilities, manufacturing processes, and contamination control systems.
Archivel Farma announces that it has received the renewal of its GMP certification for manufacturing, confirming compliance with the requirements of the new Annex 1 to produce sterile and freeze-dried products, as well as Annex 2 to produce biological products, in accordance with current European regulatory standards.
The GMP renewal is the result of a comprehensive process to upgrade the facilities, manufacturing processes, and contamination control systems. Key initiatives include the implementation of an oRABS system with SAS peroxide integrated 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 to produce small and medium batches. These technological investments will reinforce regulatory compliance, ensure product consistency, and elevate quality and safety standards.
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 thanks its investors for their commitment, as well as the dedication, involvement, and expertise of its entire team, key factors in making this transformation possible.
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.