Patient Safety

Management Approach

From early discovery through drug development, as well as while a product is on the market, Lilly prioritizes the safety and effectiveness of its medicines.

The safety and integrity of our products start with the procurement of materials and continue throughout the production process. This includes comprehensive health, safety, and environment (HSE) practices with suppliers who provide materials for research and development, as well as with contract manufacturers who produce medicines and other pharmaceutical products. Lilly also works to combat counterfeit medicines and partners with organizations committed to upholding patient safety and deterring counterfeiting.

Global Patient Safety

Beginning with the discovery of a potential new medicine, and for as long as it is available to patients, our goal is to ensure that the benefits and risks of a medication are continuously monitored and well-understood by regulators, health care providers and patients.

Our Global Patient Safety organization, with over 400 employees, is dedicated to collecting, monitoring, evaluating, and reporting safety information. Lilly collects adverse event reports and other safety data worldwide in an adverse event database. New safety findings are communicated to patients, caregivers, health care professionals and regulators through product labelling, patient information, and instructions for use.

Lilly Global Patient Safety physicians collaborate with Global Manufacturing and Global Quality colleagues to ensure the safety of our medicines by evaluating manufacturing specifications, changes, and potential issues. Additionally, the organization maintains a robust system to monitor and ensure our devices are safe and effective from development to end of life cycle.

For more information, read about our patient safety efforts.

Reliable Product Availability

Our Global Manufacturing organization's mission is to provide a reliable supply of high-quality medicines. As a medicine manufacturer, we understand our responsibility and the importance of protecting the materials needed for production and managing supply chain logistics to ensure they are available to those who rely upon them.

The Manufacturing Leadership Team oversees Lilly’s inventory of essential materials. Before these materials are received, our material and component suppliers are assessed for technical competence and their capability to supply high-quality, effective materials. Learn more about our third-party risk management.

We have robust processes for drug product components, including the active pharmaceutical ingredient and other materials used in manufacturing. Our manufacturing, packaging, and distribution capabilities help ensure the supply of safe and effective medicines. Our product serialization solution, first implemented in the U.S. in 2018 and ongoing in other countries, adds an extra layer of security and tracking for Lilly products in the legitimate supply chain.

Safety of Clinical Trial Patients

We work to find new and improved medicines through rigorous research and clinical trials. Diverse representation in clinical trials is crucial as it helps researchers develop medicines that are effective for a wide range of patients. Various factors influence how an individual responds to a treatment, including genetic background, ethnicity, gender, and lifestyle. Thus, including a diverse group of participants in our clinical trials is essential. Learn more about how we approach Clinical Trial Inclusion and Accessibility in our trials.

One of the primary responsibilities of Lilly researchers and the medical professionals who conduct our clinical trials is the safety of study participants. Participant safety and well-being are monitored throughout each clinical trial. Ethics review boards, along with independent research teams, are responsible for safeguarding the rights and welfare of clinical trial participants prior to their enrollment as well as ongoing oversight over each clinical trial throughout its duration.

Before enrolling in a clinical trial, participants are given information about the study through a process called informed consent, which continues throughout the duration of the study. This document describes the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. Participants may withdraw from a study at any time for any reason. They are also informed if new safety information emerges during the study that may influence their decision to continue participation.

Lilly sponsors clinical trials and relies on various partners to conduct them. In addition to the medical professionals at research sites, known as clinical trial investigators, we collaborate with service providers, technology providers, research monitors, and other necessary entities to effectively carry out our research. These partnerships are crucial for ensuring appropriate oversight. For example, research monitors collaborate with investigator sites to validate and confirm clinical trial data, while technology providers supply items such as electronic trial diaries or digital devices to collect biomarker data (e.g., pulse, breathing rate, body temperature). We conduct robust evaluations of these partners to ensure they meet Lilly standards for research and data privacy, and we oversee their activities throughout the clinical trial to ensure quality and data integrity.

During the clinical trial, researchers monitor patient safety by collecting any information on adverse events that occur to identify potential safety concerns. Lilly reviews these adverse events across trial participants to help inform researchers, participants and regulators how to appropriately manage the care of the research volunteers, and to inform the benefit-risk profile of our products in development.

Upholding Product Quality

Lilly is deeply committed to manufacturing high-quality medicines and ensuring product safety. We take our obligations seriously and have rigorous quality systems in place to ensure compliance with regulatory requirements.

Our Global Quality team ensures independence and objectivity by reporting directly to our CEO. The team is involved throughout the product life cycle, working across all phases of drug development and manufacturing, providing guidance and quality oversight, and collaborating with colleagues in research and development and manufacturing to comply with regulatory and internal standards.

Global Quality is responsible for managing and updating the Lilly Quality System, which is an integrated framework of standards, business processes, organizational controls, and oversight designed to help ensure that high-quality medicines are delivered to patients. This system, which also includes U.S. sales and marketing standards, supports delivering balanced, objective, substantiated and current information to our customers. It supports and reinforces the Lilly values and our commitment to operating ethically and responsibly.

In addition, Lilly emphasizes the culture of quality and has adapted a culture-focused program. Aspects of the program include leadership training and employee engagement. Lilly performs quality culture assessments of the manufacturing sites to reinforce cultural strengths and operational excellence. We work to create an environment where employees are empowered to speak up and share concerns. Learn more in our Business Ethics section.

Lilly hosts regular inspections by global regulatory bodies at manufacturing facilities, marketing affiliates and clinical areas. These inspections ensure adherence to regulations such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and quality standards. The successful outcome of these inspections supports continued reliable supply to patients while driving continuous improvement to meet regulatory expectations based on learnings from these inspections.

Lilly has a thorough process to assess potential quality defects and safety issues from internal testing, an event that potentially impacts product, quality or a complaint. Incidents posing patient risk are escalated, promptly investigated and triaged by technical subject matter experts, quality management, and safety physicians. Investigation outcomes are used for continuous process improvement.

Global Quality also oversees the following activities to safeguard product quality: 

• Testing and Assurance Checks — Testing and assurance checks are performed throughout the manufacturing process, starting with testing raw materials and components, continuing through in-process testing of active pharmaceutical ingredients, and finally, testing final products to confirm compliance with regulatory and internal specifications.

• Authorization and Regulation of Products — The Lilly Regulatory Affairs organization is responsible for the content of product submissions and any communications related to submission review and approval. They also manage post-approval product registrations, labeling, promotional materials and associated regulatory policies.

• Quality Management Training — At Lilly, employees regularly undergo training to ensure compliance with relevant enterprise quality policies. For those working in GMP (Good Manufacturing Practices) areas, we have a comprehensive CGMP (Current Good Manufacturing Practices) training program designed to prepare them to fulfill their responsibilities effectively. This program includes an annual CGMP update training that addresses current quality-related topics, industry trends, and regulatory updates. See Business Ethics for more.

• Medical Device Certifications — For our medical devices, we maintain certification to the current ISO 13485 standard and participate in the Medical Device Single Audit Program (MDSAP). In this program, multiple regulatory authorities can accept the audit from a notified body on their behalf.

Preventing Counterfeit Medicines

Illegitimate or falsified medicines endanger patient safety and disrupt regulated supply chains. Lilly’s product protection strategy has positioned us as a leader in safeguarding products against global threats like counterfeiting, tampering, theft, and diversion. We work closely with industry, government, and law enforcement agencies to protect our products.

Read additional details on the dangers of illegitimate/falsified medicine and the roles of Lilly, patients and governments in combating this issue.

See important information about our Sustainability report.