Product Stewardship

Product Stewardship

We are committed to understanding, managing and reducing the impacts of our products, and the materials associated with discovering and producing them.

 

We go to great lengths to ensure that our products are designed, made, and used in a safe, efficacious and environmentally sound manner. We deliver on this commitment by maintaining a highly trained and capable scientific staff and by actively pursuing manufacturing process improvements that minimize environmental impacts. We also collaborate with external resources and industry groups, such as the American Chemical Society and the European Federation of Pharmaceutical Industries and Associations, to ensure that our knowledge stays current with that of thought leaders and experts in the industry.

Our product stewardship program focuses on identifying and either preventing, or minimizing, potential safety and environmental hazards throughout the product life cycle. We conduct extensive testing of our products to identify and understand possible safety, health, and environmental hazards. We manage and communicate information about hazardous materials to keep our employees, contractors, transporters, and other partners safe.

Our chemists and engineers are trained in green design principles and are provided with tools and resources to help them develop manufacturing processes that use safer chemicals and lower amounts of raw materials. We use innovations like nanotechnology to make our products more effective, while ensuring that safety always remains of utmost importance.

Complying with chemical substance and product requirements is a top priority for us. We track numerous existing and emerging chemical control regulations that require us to register specific types of chemicals with the proper authorities. To meet these requirements, our scientists complete assessments of the environmental and human health risks of the substances we work with, and submit the required regulatory notifications. Additionally, we provide details on product use and risk-based control measures as necessary and in accordance with applicable regulations.

Our stewardship program extends downstream to our customers and patients through the design of effective, low impact product packaging. Our company also supports the development of science-based, cost-effective, and environmentally sound programs that promote the proper disposal of unused medicines in accordance with regional requirements. For more information, see our position statement on responsible disposal of medicines.

PRECAUTIONARY PRINCIPLE

We take a precautionary approach when evaluating potential human exposures and environmental impacts resulting from our manufacturing processes. Conservative assumptions are made when data are limited, and safety factors are added to address uncertainty and variability in our assessments.

This type of approach is particularly relevant to our work in toxicology, industrial hygiene, and environmental protection.

  • Using the results of our scientific studies, we determine hazard ratings for all of our chemical compounds, and default to more conservative exposure limits when we have limited health hazard information. We use a rigorous and data-driven review process, and we often find that our initially conservative default ratings can be relaxed as additional preclinical and clinical data become available.
  • Our Industrial Hygiene Risk Assessments require that the effectiveness of engineering controls be verified, and that exposure monitoring be conducted as necessary to ensure appropriate levels of employee protection. We evaluate exposure-monitoring data on the basis of statistical analysis, not just individual point-by-point comparisons to Occupational Exposure Limits, providing an even greater assurance of employee safety.
  • We use conservative safety factors to set low de minimis levels for environmental releases until we have sufficient data to fully understand impacts on aquatic organisms. Aquatic testing is typically completed late in the product development timeline, and limits are often revised upward once those data become available.