Introduction
Environmental requirements in medicines purchasing increasingly include antibiotic manufacturing controls that are intended to reduce antimicrobial resistance (AMR). The practical focus is on preventing the release of antibiotic active pharmaceutical ingredients (APIs) and biologically active residues into water and waste streams at levels that may select for resistant bacteria. These expectations sit alongside broader procurement environmental criteria, but differ in one respect: purchasers treat them as directly linked to the long-term effectiveness of antibiotics, rather than as a purely ecological or reputational issue.
Why antibiotic discharges have become a procurement issue
Evidence from multiple settings shows that antibiotic residues in aquatic environments can create selection pressure that supports the emergence and persistence of resistance mechanisms. This has led purchasers and public bodies to frame manufacturing emissions as part of the AMR problem that can be influenced through tender requirements, particularly where antibiotics are procured at scale and where supply chains include multi-tier production and contract manufacturing.
In practice, procurement mechanisms are being used to translate high-level AMR commitments into requirements that suppliers can be assessed against, monitored over time, and held accountable for through contract terms. The Norwegian Hospital Procurement Trust (Sykehusinnkjøp HF, NHPT) explicitly describes environmental criteria in pharmaceuticals procurement, including antibiotics, as a structured programme with defined requirements, scoring approaches, and follow-up.
What is being controlled at site level
Controls in this area are typically framed around three linked elements.
First, identifying the relevant waste streams across both API manufacture and finished-dose manufacture, including process wastewater, cleaning wastewater, and solid waste contaminated by antibiotic agents. WHO guidance explicitly covers both wastewater and solid waste management for antibiotic manufacturing.
Second, defining performance targets for emissions. A common reference point is the “presumed-no-effect concentration” (PNEC), which is a concentration below which adverse effects are not expected, including resistance selection in relevant contexts. Procurement requirements may ask suppliers to describe routines and controls designed to achieve PNEC-based targets for the relevant API at the relevant production stages.
Third, implementing management routines that are auditable. These typically include documented procedures for treatment and disposal, defined responsibilities, supplier oversight where manufacturing is outsourced, and evidence that controls are operational rather than aspirational. NHPT’s experience report sets out this preference for specified routines and the ability to document them on request, including where third-party manufacturers are used.
Standards and assurance mechanisms used by purchasers
Purchasers increasingly prefer assurance through defined standards and independent verification rather than narrative sustainability statements. In antibiotics, a central reference point has been the AMR Industry Alliance Antibiotic Manufacturing Standard, which is positioned as a manufacturing standard intended to combat AMR risk throughout the supply chain. NHPT references this standard directly and links it to independent certification routes.
WHO’s guidance is framed for a wider audience that includes procurers, reimbursement decision-makers, and third-party audit bodies, and describes progressive implementation and stepwise improvement, reflecting the need to balance emissions control with continued access and security of supply.
A related development is the creation of certification options designed to demonstrate that manufacturing sites and supply chains meet defined expectations. The British Standards Institution (BSI) launched a “Minimized Risk of Antimicrobial Resistance” certification linked to responsible antibiotic manufacturing, intended to provide auditable proof for customers and public purchasers.
How these requirements appear in tendering and contracting
Tender implementation tends to use one or more of the following approaches.
One approach is scoring, where environmental criteria influence award decisions. NHPT describes procurement processes in which environmental requirements can be weighted as award criteria, including historic antibiotic procurements where environmental performance was given material weight.
A second approach is eligibility or threshold requirements, where suppliers must demonstrate compliance with a specified standard or show that certification has been initiated. Nordic joint work has formalised this via shared environmental criteria applied in tendering procedures, with documentation and certification expectations described as part of the route to the highest scoring outcomes.
A third approach is embedding requirements into a broader commercial model. In the United Kingdom, NHS England’s Antimicrobial Products Subscription Model is accompanied by commercial guidance, and communications associated with the model indicate that bidders are expected to demonstrate responsible antibiotic manufacturing through certification to the relevant standard.
Across these approaches, the common operational requirement for manufacturers is the ability to provide consistent, verifiable evidence for relevant sites and tiers of the supply chain, and to maintain that evidence during contract execution rather than only at bid submission.
Evidence and documentation that manufacturers are expected to provide
The evidence requested by purchasers typically falls into three categories.
The first is management-system evidence, such as documented environmental management routines, supplier agreements covering environmental controls, and audit processes. NHPT describes requirements that distinguish between supplier-owned production and third-party manufacturing, and links higher scores to demonstrable systems for risks, routines, audits, and sanctions, including third-party certification.
The second is performance-target evidence, commonly framed around achieving defined discharge limits or demonstrating routines intended to achieve PNEC-based targets for specific substances. This may include identifying the PNEC value used and its source, and explaining how the target is operationalised in wastewater treatment routines.
The third is independent assurance, such as certification to the AMR-relevant manufacturing standard or an equivalent framework, and evidence of certification initiation where full certification is not yet complete. Nordic tendering documentation and NHPT experience reporting both indicate that third-party certification is treated as the strongest form of assurance when available.
Service and supplier landscape supporting compliance
A practical consequence of this trend is a growing ecosystem of service providers that support manufacturers in implementing controls, generating evidence, and providing assurance.
BSI provides a certification route intended to attest to responsible antibiotic manufacturing and minimised AMR risk, aligned with the relevant manufacturing standard.
Environmental advisory consultancies are also positioning support around pharmaceutical water quality, supply-chain oversight, and adoption of recognised standards for controlling API discharges. ERM, for example, describes work on water quality in the pharmaceutical value chain and explicitly references responsible wastewater management and relevant standards used in the sector.
On the engineering and treatment side, providers such as Veolia Water Technologies describe pharmaceutical wastewater treatment and API removal solutions, including technologies intended to address micropollutants and reduce environmental risks associated with pharmaceutical waste streams.
Analytical and monitoring providers, including Eurofins, offer accredited testing services for pharmaceuticals in wastewater, supporting monitoring and documentation needs where purchasers or regulators request residue evidence.
Summary
Manufacturing emissions and residues for antibiotics are increasingly addressed through procurement requirements because they are linked to AMR risk, not only to general environmental performance. Control expectations focus on identified waste streams, operational routines for treatment and disposal, and performance targets often linked to PNEC-based approaches. Public guidance from WHO provides a scientific basis intended for regulators, procurers, and reimbursement decision-makers, including stepwise implementation concepts. In Europe and the Nordic region, tendering procedures already reference defined standards and, in some cases, treat third-party certification as the strongest form of evidence. The UK antibiotic subscription model has also been linked publicly to certification expectations for responsible antibiotic manufacturing. Manufacturers therefore increasingly need auditable assurance mechanisms and supporting services across certification, advisory support, treatment engineering, and residue monitoring.
Links
Scientific publications
Barathe P, Kaur K, Reddy S, Shriram V, Kumar V. Antibiotic pollution and associated antimicrobial resistance in the environment. J Hazard Mater Lett. 2024;5:100105. doi: 10.1016/j.hazl.2024.100105
Cameron A, Connolly N, Esiovwa R, et al. ‘Mind the gaps’: stakeholder perspectives on addressing antimicrobial resistance in the environment in the Indian context. Glob Health Action. 2025;18(1):2491200. doi:10.1080/16549716.2025.2491200
Jahre M, Van Oorschot K, Årdal C, et al. Sustainable pharmaceutical procurement: Environmental tendering criteria for better or worse? J Purch Supply Manag. 2025;101081. doi: 10.1016/j.pursup.2025.101081
Kraupner N, Hutinel M, Schumacher K, et al. Evidence for selection of multi-resistant Escherichia coli by hospital effluent. Environ Int. 2021;150:106436. doi: 10.1016/j.envint.2021.106436
Larsson DGJ, Flach C-F. Antibiotic resistance in the environment. Nat Rev Microbiol. 2022;20:257-269. doi: 10.1038/s41579-021-00649-x