Risk Assessment and Segregation Strategy for Hormone Production at Sterile Manufacturing Facility

Client: Sterile Manufacturer
Duration: 8 Months
Project Role: Hands-on Project Lead - GMP Bridge Senior Partner

Location: Germany

GMP Bridge was engaged by a sterile manufacturer to support the introduction of a hormone product into their facility—marking the first hormone to be produced at the site. The project required a detailed risk assessment and the development of a robust segregation strategy to ensure the safe and compliant production of this new product. Our Senior Partner led the project, working closely with the client’s team and German health authorities to achieve the Health Authority approval.

• Comprehensive Risk Assessment: Conducted an in-depth risk assessment to evaluate the potential impact of introducing hormone production in the sterile facility. This included assessing cross-contamination risks, environmental controls, and operational procedures to ensure safe and compliant manufacturing.
• Segregation Strategy Design: Developed a custom segregation strategy tailored to the client’s needs, ensuring the hormone product would be produced in a controlled and isolated environment. This included designing separate production zones, specialized equipment protocols, and stringent cleaning procedures to prevent contamination.
• Stakeholder Collaboration: Worked closely with the client’s internal teams, including quality assurance and operations, to implement the strategy and ensure a seamless integration of hormone production into their existing processes.
• Approval from Health Authorities: Facilitated discussions with German regulators to address any concerns, resulting in the successful approval of the proposed strategy.

• Regulatory Approval: The German health authorities approved the segregation strategy, enabling the client to proceed with hormone production at their sterile manufacturing facility.
• Operational Readiness: The project ensured that the facility was fully prepared to produce the hormone product in compliance with regulatory standards, without compromising the safety or quality of other products.
• Enhanced Compliance & Safety: The implementation of the segregation strategy improved the overall safety and compliance of the facility, reducing the risk of cross-contamination and ensuring the integrity of all sterile manufacturing operations.