Behind the Scenes of a GMP Win

CARBOGEN AMCIS recently announced the achievement of Good Manufacturing Practice (GMP) certification for its sterile drug product facility in Saint-Beauzire, France, following a successful inspection by the French regulatory authority, ANSM. But what challenges did the company face? And what does the future hold? We spoke with Julie Pagenaud, Director of Pharmaceutical Operations, Drug Products, at CARBOGEN AMCIS to find out.

What specific criteria are assessed during an ANSM inspection?

The ANSM inspection was a key milestone for our Saint-Beauzire site, which opened in February 2023. As part of the standard regulatory process, this first routine inspection aimed to ensure full compliance for aseptic drug product manufacturing.

During the inspection, the ANSM inspectors conducted an in-depth evaluation of several critical areas, including:

• Quality system: A review of our processes to ensure robust quality management and compliance with regulatory requirements, with a high focus on data integrity.
• Risk assessment: A detailed evaluation of our risk management analysis and systems to mitigate potential issues in sterile manufacturing.
• Technology Transfer: An analysis of our procedures and strategies to seamlessly integrate new processes and products.
• Validation Strategy and Aseptic Process Simulation (APS): An assessment of our approach to process validation and APS to ensure sterility assurance.
• Process validation: A verification that our processes consistently produce products meeting predetermined quality standards.
• Annex 1 compliance: Confirmation that our facility meets the latest EU GMP Annex 1 standards for sterile manufacturing.
• Computer system validation: A review of our status and validation protocols and reports.
• Facility Inspections: Detailed shop floor visits and observations closest to the activity to assess infrastructure, cleanroom operations, and adherence to aseptic processing protocols.

What were the key challenges faced in preparing for the inspection?
 

Preparing for the ANSM inspection was both a technical and human adventure! It required a fine balance between building our team, ramping up production, and ensuring compliance with stringent regulatory requirements.

One of the key challenges was that, while we were preparing for our first GMP inspection, we were already manufacturing under an initial authorization. This meant that our teams had to simultaneously build and train a highly skilled team in a newly established facility; ensure readiness for inspection while maintaining smooth production operations; and align production timelines with regulatory requirements, ensuring all necessary processes and documentation were in place for ANSM’s review.

Thanks to strong collaboration across departments, a rigorous preparation plan, and the commitment of our teams, we successfully met ANSM’s expectations and secured our GMP certification.

What measures are in place to maintain ongoing compliance with GMP standards?
 

Maintaining GMP compliance is a top priority. We ensure this through a structured approach centered on continuous improvement. Our global strategy aligns site and individual goals, integrating compliance, environmental safety and health, corporate social responsibility, and financial sustainability. Continuous training keeps our teams up to date with evolving standards and technologies, and our leadership team actively engages on the shop floor, ensuring strategic decisions match operational realities and drive quality.

Are there plans to pursue additional certifications or approvals from other regulatory bodies?

Yes, securing GMP certification from ANSM is just the beginning. To further strengthen our global compliance and expand our market reach, we are actively working towards obtaining additional regulatory approvals, including from the FDA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

These approvals will expand our market access and enable us to manufacture commercial aseptic drug products for the US and Japanese markets. We already manufacture clinical products for those regions, but further approvals will reinforce our global regulatory compliance.

We are also planning investments to expand the site further and increase our capacity in high-growth areas such as antibody-drug conjugates.

What insights or lessons learned from this certification process can you share that might benefit other facilities?
 

One of the key takeaways was the importance of having inspectors who are highly technical and knowledgeable about the field. During the inspection, the ANSM inspectors conducted detailed on-the-ground verification of our processes, which required a high level of technical competence. This hands-on approach was particularly insightful, as it underscored the importance of ensuring that our strategic plans are aligned with day-to-day operations on the shop floor.

Additionally, we learnt the value of coherence between strategy and execution. The inspectors’ technical expertise highlighted the need for continuous alignment between high-level strategies and practical, real-world implementation to ensure long-term GMP compliance.