Compliance frameworks, security audits, and quality certifications this company maintains.
Regulatory
FDA 21 CFR Part 211
CompliantEli Lilly's manufacturing facilities operate under FDA 21 CFR Part 211 Current Good Manufacturing Practice regulations, governing pharmaceutical production, testing, and quality controls for all drug products marketed in the United States, including Mounjaro and Zepbound.
Lilly applies ICH Q10 Pharmaceutical Quality System guidelines across its global manufacturing network, establishing a lifecycle-based quality framework that supports process understanding, risk management, and continuous improvement for injectable drug products.
Regulatory
GCP (ICH E6 R2)
CompliantAll Lilly clinical trials — including the SURMOUNT obesity trials, SURPASS diabetes program, and TRAILBLAZER-ALZ Alzheimer's studies — are conducted under ICH E6 R2 Good Clinical Practice guidelines to ensure data integrity, patient safety, and regulatory acceptance globally.
Lilly's European manufacturing operations and supply chain comply with EMA Good Manufacturing Practice guidelines, enabling commercial distribution of Mounjaro, Zepbound (as Wegovy equivalent), Verzenio, and other products across EU member states.
Eli Lilly's LillyDirect patient access platform and clinical data systems comply with HIPAA Privacy and Security Rules, safeguarding protected health information for patients enrolled in savings card programs, home delivery services, and clinical trial registries.
Lilly's European operations and global clinical data systems comply with GDPR requirements for the collection, processing, and transfer of personal health data from EU-resident clinical trial participants, patients, and healthcare professionals.
Lilly's major manufacturing sites including Indianapolis, Branchburg NJ, and Kinsale Ireland hold ISO 14001 certification for environmental management systems, supporting Lilly's commitment to achieving net-zero greenhouse gas emissions by 2050 across its supply chain.
Lilly's pharmaceutical manufacturing plants and research campuses operate under ISO 45001 occupational health and safety management systems, providing structured hazard identification and risk control for employees handling high-potency active pharmaceutical ingredients.
Regulatory
PhRMA Code on Interactions
CompliantLilly adheres to the PhRMA Code governing interactions with healthcare professionals, including restrictions on gifts, meals, and speaker fees — policies enforced through annual training for all commercial and medical affairs employees globally.
Regulatory
Sarbanes-Oxley (SOX)
CompliantAs a NYSE-listed company, Eli Lilly maintains SOX Section 302 and 404 compliance across its financial reporting systems, with annual internal control audits covering its global ERP infrastructure, clinical trial accounting, and revenue recognition processes for drug sales.