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.

AMR Manufacturing Key Issues and Challenges

In the recent years, the growing threat of antimicrobial resistance has prompted coordinated and concerted efforts to develop more sustainable antimicrobial development, management and use. One of those efforts resulted in over 100 companies and industry associations signing the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance in 2016, followed by the adoption of the Roadmap for Progress on Combating AMR by 13 pharmaceutical companies. These two documents constitute the basis of the AMR Industry Alliance work. In January 2018, the Alliance released its first progress report which includes major progress achieved in innovation, stewardship, access and manufacturing-related releases. The findings presented include industry insights by the companies surveyed, as well as certain challenges that were identified along the way.

One of the four major pillars of the Alliance’s work is related to controlling manufacturing-related releases, which is considered a key element of sustainable action against combating antimicrobial resistance. The Roadmap signatories are committed to being part of the solution and are actively working to deliver on the four commitments they have endorsed.

What has been achieved?

The industry Roadmap signatories have already made significant progress on two of the objectives related to manufacturing-related releases, as well as made important progress in establishing science-based targets for antibiotics discharges:

  • Roadmap companies reviewed and are assessing their manufacturing and supply chain practices to ensure control of antibiotics discharges and are performing regular audits;
  • Roadmap companies have developed and published a common framework for managing antibiotic manufacturing-related releases as set forward by the Alliance Roadmap, and;
  • Companies have collated, shared and analyzed existing antibiotic eco-toxicity data and relevant peer-reviewed science to facilitate the development of unified approach to establish discharge limits.

What are the next steps?

The signatory companies are committed to further work towards meeting the Roadmap targets, including:

  • Developing a practical mechanism that would transparently demonstrate the framework standards are being met;
  • Working with independent experts to establish science-driven, risk-based targets to reduce environmental impact of manufacturing-related releases by 2020; and,
  • Expanding the adoption of the framework to more companies to increase its impact.

How can we address the challenges?

Success in these areas can only be achieved through a collaborative approach between multiple stakeholders, including policymakers, public health institutions, academia and industry. Some of the challenges identified by the Alliance to support industry’s progress are:

  • Lack of consistent enforcement of national and local discharge regulations;
  • Absence of an agreed-upon method to determine environmentally acceptable discharge levels of antibiotic residues in wastewater; and,
  • Identifying common mechanisms to transparently demonstrate supply chains meet standards in the framework.

To help overcome these challenges, the Roadmap companies have conducted important stakeholder engagements with the academic and research community, with multinational organizations and with industry groups to review and validate the direction of the group; and will continue to do so going forward. To further the impact of the Roadmap targets, including the recommendations from the framework to reduce manufacturing discharge, the Alliance is continuously working towards increasing the number of committed companies.

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