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We are committed to providing the highest-quality products and ensuring product integrity. From development through commercial manufacturing and distribution, we protect the entire product life cycle with a variety of controls and monitoring tools. These include an integrated team that addresses counterfeiting, product tampering, theft and diversion issues along with:
Our unwavering commitment to product quality is essential to the lives of our patients and critical to the success of the work we do at Bristol Myers Squibb. We are committed to providing products and services that meet or exceed customer expectations and regulatory requirements and deliver superior value and quality. Our value chain ensures that our medicines—from design, development, manufacture and distribution through disposal—meet preestablished safety, efficacy, purity and quality standards.
We care about the communities where we operate, and we conduct our business in an environmentally sustainable manner. We integrate principles of resource conservation, pollution prevention and environmental responsibility into our business processes, facilities, operations and products. In addition, we collaborate with the government, industry, educational institutions and the public to support regulations, research and programs that address environmental, health and safety concerns. We consider environmental protection and personal and public health and safety essential parts of our everyday responsibilities, and recognize that the integrity of natural systems—our land, water, air and biodiversity—is critical to both economic and environmental vitality. Therefore, we take a precautionary approach when there is potential harm to human health or the environment.
Our sector is one of the most highly regulated industries because human health and life are at stake. We comply with all laws and regulations in the jurisdictions in which we operate. Most notably, the regulations for current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Pharmacovigilance (PV) and current Good Distribution Practice (cGDP), are incorporated into our ways of working.
Our quality management system (QMS) is a series of standards and business processes that assure we achieve our intended quality outcomes across the spectra of regulatory frameworks. It defines our ways of working, our strict specifications for manufacturing, testing and packaging, and controls to make sure that our outcomes are continuously as intended. We align our QMS to global, industry-recognized standards and guidelines to build a comprehensive and complete quality framework that is agile enough to respond to change.
Pharmaceutical companies are regulated by health authorities worldwide, such as the FDA in the U.S., and European Medicines Agency (EMA) in Europe. Since we develop and manufacture combination products and medical devices, we are also regulated by ISO 13485.
In addition, we are audited by these health authorities on a regular basis. In 2020, we completed over 100 regulatory inspections.
We have started a multi-year journey to transform our QMS across the product life cycle into a common GxP framework.
Our approach involved the creation of an integrated quality philosophy across the entire product life cycle. We are also driving progress towards cloud-based quality applications. These are building the foundation for predictive quality, and we feel we have a strong program in place to achieve this vision.
The BMS Quality Management System (QMS) is a demonstrable and harmonized series of practices and standards that help us to achieve intended outcomes “right the first time.” It is a transparent and uniform way to ethically and rigorously achieve outcomes. Further, our QMS employs closed-loop, continuous improvement mechanisms to ensure transparency of results and willingness to act based on outcomes.
