USP Compliance: A Guide for Pharmaceutical Manufacturers
Pharmaceuticals manufacturing — By May 2026, manufacturers must comply with the newly released USP<665> from the United States Pharmacopeia. These guidelines establish strict safety standards for polymeric plastic components used in pharmaceutical production, particularly those in direct contact with products. As the application of single-use technologies from tubing to bioreactors expands, USP<665> addresses the risks of Extractables and Leachables (E&L), enhancing patient safety and drug purity.
Manufacturers are required to rigorously assess and select plastic materials that meet specific safety criteria. This involves evaluating material for chemical resistance, purity, and stability. This stringent selection process may restrict the available materials, potentially leading to higher costs and alterations in supplier relationships.
Manufacturers may also need to overhaul existing production processes. This could include modifying equipment, changing fabrication techniques like molding and extrusion, and implementing new handling procedures to reduce contamination risks. Such modifications require planning, time, and financial resources, impacting production timelines and possibly leading to temporary reductions in manufacturing efficiency.
The guidelines further mandate detailed testing for E&L, requiring manufacturers to develop, validate, and routinely execute solid testing protocols. This implies investments in advanced analytical capabilities and training for technical staff, potentially leading to the creation of dedicated labs for ongoing compliance. Additionally, rigorous quality control measures are essential, involving tight inspection of materials, process monitoring, and comprehensive testing of final products to ensure compliance with safety standards.
Preparing for change
— Pharmaceutical companies can prepare for USP<665> by adopting a proactive and strategic approach. This includes reviewing and adjusting their current processes and materials focusing on risk assessment for E&L. They need to identify gaps in compliance, invest in targeted staff training, and collaborate with suppliers to ensure that materials meet new standards. Adopting a risk-based approach helps prioritise efforts when they are most needed.
The transition to USP<665> compliance may present several challenges for manufacturers. Resource limitations could restrict the ability to implement necessary changes swiftly, while a lack of specialised technical expertise could complicate testing and data interpretation. Additionally, managing compliance across intricate supply chains requires strong coordination and communication, ensuring that all suppliers adhere to the new standards.
To support this significant transition, ALTEN offers specialised services to help clients in achieving USP<665> compliance. With our deep expertise in E&L testing, we provide essential resources and knowledge to navigate these complex requirements. By facilitating the early adoption of USP<665> guidelines and delivering strategic support, ALTEN helps its clients stay ahead of regulatory shifts and maintain a competitive edge in the pharmaceutical industry.
Looking ahead
— USP<665> promises transformative changes across the life sciences industry by establishing higher safety and quality benchmarks. This new standard compels manufacturers to rethink their production processes, encouraging the use of innovative materials and cutting-edge analytical techniques. These advancements are expected to enhance manufacturing robustness, significantly boosting the safety and quality of pharmaceutical products.
Adopting USP<665> goes beyond compliance; it’s a strategic opportunity to enhance operational excellence. Companies that proactively embrace these standards can improve compliance and differentiate themselves in the marketplace. This strategic advantage can boost their reputation for quality and reliability, strengthen competitive positioning, and build deeper trust with healthcare professionals and patients.
The successful transition to USP<665> compliance hinges on effective collaboration among various industry stakeholders, including regulatory bodies, material suppliers, and service providers. By working together, these parties can align with the new guidelines, overcome transitional challenges, and share valuable insights. This collaborative approach is essential for promoting continuous improvement and innovation, ultimately improving patient outcomes and streamlining drug manufacturing processes.
— In short, USP<665> advances pharmaceutical manufacturing, enhancing safety and quality while demanding adjustments from manufacturers. Companies must innovate and adapt, investing in new technologies and methods to meet stringent standards and ensure ongoing improvements in product quality and patient safety. Industry-wide collaboration is crucial for successful adaptation. Together, we can transform the challenges of USP<665> into opportunities for growth and advancement, setting new benchmarks for pharmaceutical practices and enhancing global healthcare outcomes.
