Common Antibiotic Manufacturing Framework

The major source of pharmaceuticals entering into the environment is via patient excretion following use of medicine that is taken to prevent, cure or alleviate a medical condition. A comparatively smaller contribution to PIE stems from emissions from industry during manufacture of the pharmaceuticals.

While the overall contribution of pharmaceutical manufacturing to PIE is relatively low, there is the potential for localized impacts to be created in cases where manufacturing emissions are inadequately managed. Ensuring the use of appropriate environmental risk management measures to adequately control manufacturing effluent emissions remains an important area of focus for the pharmaceutical industry and is an approach already in place in a number of companies. We are aligned in our intent and are ready to build and share common practices.

Reports of active pharmaceutical ingredients (APIs) in water from pharmaceutical manufacturing indicate concentrations have reached potentially harmful levels when wastewater discharges are not sufficiently controlled at some facilities, highlighting the importance of effective control of API emissions from manufacturing, both in production of the API itself and its formulation into drug products for patient use.

Environmental regulations pertaining to wastewater discharges from manufacturing, already generally apply to pharmaceutical production. However, many socially and environmentally responsible companies go beyond compliance with the basic regulatory requirements for chemical manufacturers (e.g., control of pH, biological oxygen demand, chemical oxygen demand) and establish environmental protection goals to evaluate and reduce potential environmental risk from production of their products.

Currently, most programs focus on potential toxicity to aquatic species, upsets to wastewater treatment plants or potential toxicity in human drinking water. Emission limits, specifically for preventing antimicrobial resistance, are currently under development. The AMR Roadmap signatories are committed to achieving this goal and are reliant on the evolving science as a means to arriving at a consistent methodology for these limits by 2020.

The Antibiotic Manufacturing Framework provides a methodology and set of minimum requirements needed to conduct a site risk evaluation of both macro and micro controls in our supply chains. Company expectations, including this Framework, will be communicated within the AMR Roadmap signatory companies and their supply chains.

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