Product Safety
Behind every therapy we deliver is a rigorous quality management system, a carefully managed supply chain, and a team committed to getting it right — every time.
Protecting our patients
At Insmed, a patient-first mindset and a culture of quality and integrity are inseparable. Every Insmed employee is trained on our Code of Business Conduct and Ethics when they join the company and annually thereafter. Teams complete role-specific training to sustain excellence across the organization. Our Executive Committee receives regular updates on quality metrics and supply chain performance, ensuring accountability at every level. Through our Global Healthcare Compliance Program, we continuously monitor adherence to our Ethical Marketing standards — turning policy into practice and reinforcing our end-to-end commitment to quality, integrity, and patient safety.
2025 Highlights
100% of employees
completed Code of Business Conduct and Ethics training
98% of employees
completed role-specific quality training
Upholding the highest standards
Insmed holds itself — and every partner we work with — to the highest regulatory standards. Using a risk-based approach, our audit program assesses our operations and those of our Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), Investigator Sites, and other suppliers for compliance with FDA GxPs. Prior to engagement, our Quality Assurance team vets every CRO and CMO for GxP adherence, and we require direct suppliers to manage training in line with global regulations and GxP regulations. Deviations are met swiftly with structured Corrective Actions and Preventive Actions.
FDA GxPs include:
- Good Laboratory Practice
- Good Clinical Practice
- Good Manufacturing Practice
- Good Distribution Practice
- Good Pharmacovigilance Practice
Enabling safe supply
Our supply chain management (SCM) program maintains commercial-scale, dependable supply through proactive inventory monitoring and demand forecasting — helping to provide patients with access to the treatments they need. Regulatory-required serialization controls, including unique serial numbers on product packaging, help safeguard supply chain integrity and promote full traceability. Our SCM team meets regularly with direct suppliers to evaluate regulations, performance metrics, and market conditions, while our Pharmaceutical and Analytical Development team rigorously tests every product batch against critical quality attributes. Underpinning it all, our Supplier Code of Conduct sets clear expectations for ethical conduct, human rights, environmental health and safety, and quality.
Monitoring & reporting
At Insmed, pharmacovigilance (PV) — the continuous monitoring of our therapies to track patient outcomes and promote regulatory compliance — is central to everything we do. We align our PV policies with World Health Organization (WHO) standards and country-level guidance, including 21 CFR in the U.S., and fully comply with the Drug Supply Chain Security Act to enable product traceability and controlled distribution. Our Vice President of PV meets weekly with our Chief Medical Officer, a member of the Executive Committee, helping to foster accountability at the highest level of leadership.
In addition, our PV Policy and SOPs set clear expectations for all personnel. All employees and full-time contractors complete PV training during onboarding and annually thereafter. We audit our PV practices through internal reviews and independent third-party assessments and conduct an annual mock recall with third-party logistics providers to stay ready for real-world safety events.
2025 Highlight
100% of employees and contractors
completed PV training
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