Experience for Process Success
Regulators around the world are enthusiastic about continuous pharmaceutical processing, but no specific guidance exists. The US FDA has only communicated expectations of high-level continuous process understanding and a strong preference for advanced sensing and process control methodologies. Our team’s comprehensive understanding of regulatory processes and expectations is a fundamental differentiator of working with Integra Continuous Manufacturing Systems, and the key to enabling your process success.
Integra Continuous Manufacturing Systems team members have worked with FDA and industry, including supporting FDA through consultations and training programs. Via C-SOPS, we have also participated in multiple FDA-funded projects focusing on how to develop and implement continuous processes to achieve optimum performance.