ICM Farmak Expands GMP-Certified Capabilities with In-House Sterility Testing

The expanded authorization has been incorporated into the site’s updated Good Manufacturing Practice (GMP) certificate. It enables ICM Farmak to conduct in-house all analytical testing required to support the release of sterile medicinal product batches, strengthening the site’s quality control capabilities and reducing its reliance on external testing.

The next stage in ICM Farmak’s development

The authorization follows ICM Farmak’s first EU GMP certification, received in December 2025. That certification confirmed the site’s compliance with European Union requirements for the manufacture of sterile pharmaceutical dosage forms, including aseptic filling and terminal sterilization.

Adding microbiological sterility testing to the site’s authorized activities is the next step in developing a comprehensive sterile manufacturing and quality control platform in Spain. Performing this critical testing internally provides greater oversight of the analytical process and further strengthens ICM Farmak’s operational independence.

Bringing sterility testing into our own laboratories gives us greater control over a critical part of the quality process and represents another important step in the development of our site. This authorization was achieved through close collaboration across several departments, and I am proud of the expertise, dedication and commitment our teams demonstrated throughout the process.

Juan Antonio de la Fuente General Manager, ICM Farmak Manufacturing Site

The achievement reflects the coordinated efforts of teams across multiple departments and their commitment to meeting the highest GMP standards. It further reinforces ICM Farmak’s focus on quality, regulatory compliance, patient safety and operational excellence.

Located in Barberà del Vallès, near Barcelona, the ICM Farmak facility specializes in manufacturing sterile injectable medicines. The site combines aseptic processing and terminal sterilization capabilities with analytical, microbiological and quality control laboratories.

The expanded GMP scope strengthens ICM Farmak’s position as a reliable manufacturing partner for sterile medicinal products and supports the continued development of the site’s capabilities for regulated healthcare markets.

About ICM Farmak

ICM Farmak S.L.U. is Farmak International’s manufacturing facility in Spain, focused on the production of sterile injectable medicines. The site specializes in Injectable Critical Medicines and provides aseptic and terminally sterilized manufacturing and quality control capabilities in compliance with EU GMP requirements.