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Integrating EHS Activities With Lilly New Product Development
Product stewardship - the passage of a new pharmaceutical from discovery through development to launch - takes many forms. One of the most important forms at Lilly is the environmental, health and safety efforts that help bring a new product to market. We believe that identifying, evaluating and integrating EHS issues into a product's development at the earliest stages of its life cycle enhances our EHS performance and makes good business sense.
Under the New Product Environmental Requirements Tracking (NPERT) process, environmental issues are identified and addressed from the very beginning. The NPERT process mandates that the Pharmaceutical Process Development team (PPD team) identify and quantify the raw materials used and the wastes generated at each process step. The PPD team uses the waste management hierarchy to determine how best to minimize the waste generated in the manufacturing process, giving priority to source reduction, then recycling, and so on. The PPD team identifies the hazards and the difficulties in treating the waste associated with the raw materials and processing to determine if chemical substitutions are desirable and possible. If a substitute is not possible, then consideration is given to recycling, treatment, and ultimately disposal.
Waste Management Hierarchy

Lilly has witnessed many examples of the environmental benefits of the NPERT process since its inception. Two of the most interesting involved the new drug products olanzapine, a drug used for the treatment of schizophrenia, and raloxifene, a drug used for the treatment of postmenopausal osteoporosis. The brief case studies that follow tell about the significant EHS activities that took place to support the development and ultimate launch of these new compounds. These ventures called upon the talents of EHS employees all over the world. Their dedicated efforts played a major role in the development of these products.
Olanzapine Case Study
Raloxifene Case Study
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