Leveraging Contract Packaging For Greener Pharma Solutions

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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GlobalData’s analysis happens to reveal quite a significant uptick in the mention of emissions within pharmaceutical company filings. In 2023, this keyword appeared 6,272 times—a 33% increase from the previous year and a staggering 542% rise from 2016. This highlights the growing emphasis on sustainability across various industries as the pressure to meet net-zero emissions targets intensifies. While there are some large pharmaceutical companies that look to aim so as to achieve carbon neutrality soon, many have committed to a 2030 deadline. Considering the kind of vast changes that are required and the predicted rise in the demand for carbon-intensive products like injectables, the urgency is palpable.

Balancing Demand and Sustainability in Pharma Production

As global populations age and of course the access to medications in developing regions improves, the pharmaceutical industry faces escalating demand. Innovations and new therapeutic modalities, such as the latest weight loss and diabetes drugs, further drive this dependency on medicines. GlobalData projects sales of GLP-1 agonists to reach $37.1bn by 2031. This situation begs the question: how can the industry reduce emissions while the demand for its products continues to grow? Hywel Woolf, Sustainability Manager at Sharp, stressed that energy efficiency improvements and sustainable sourcing programs are essential.

Woolf highlighted that the US pharmaceutical sector alone consumes over $1bn of energy annually, with this figure on the rise. He pointed out that reducing energy usage, sourcing renewable energy, and improving energy efficiency could lead to better environmental outcomes and financial savings. Simple modifications in offices and manufacturing sites, such as motion sensor-based LED lighting, can make a significant impact. However, larger investments are also necessary, including HVAC upgrades, building insulation, and installing solar panels and geothermal wells. GSK and Merck have disclosed that Scope 3 emissions constitute a broader portion of their carbon footprint, underscoring the importance of supply chain partners committed to sustainability.

Importance of Eco-Design in Pharmaceuticals

Integrating eco-design principles throughout product development is crucial for reducing carbon emissions, especially given the industry’s contribution of 300 million tonnes of plastic waste annually. Injectable drug delivery devices, such as autoinjectors, pens, and prefilled syringes, heavily rely on high-carbon footprint materials and single-use plastics, necessitating significant redesigns to lower their embedded carbon.

Opportunities and Challenges in Eco-Design for Injectables

Eco-design is essential for the future of injectable pharmaceutical products. Single-use plastic devices present a significant problem but also an opportunity for improvement. Switching to multi-use devices could have a huge impact. Redesigning devices for easier disassembly and reuse, as well as simple changes like limiting device colors, could enhance recyclability. Woolf suggested that using fewer colors could facilitate recycling and prevent plastics from ending up in incineration. Regulatory support for such changes could also be beneficial.

Glass, while easier to recycle than plastic, faces limitations due to contamination concerns, placing emphasis on virgin glass production, which is more carbon-intensive. Alexander Schäfer, Business Development Manager at Sharp, explained that the pharmaceutical industry operates in a heavily regulated market, posing challenges for sustainable changes. Sustainable sourcing, such as finding vendors who use green energy, becomes crucial. Schäfer noted that viable alternatives are often limited, especially for primary packaging, though secondary packaging materials offer more sustainable options.

Role of CPOs in Sustainable Pharma

Pharmaceutical companies are increasingly relying on contract packaging organizations- CPOs for support and advice on sustainable options, marking a shift in the traditional client-CPO relationship. Collaborations with suppliers and CPOs are now key to achieving sustainability goals, especially in reducing the carbon footprint of injectable devices. Schäfer mentioned that CPOs can influence sustainable choices by presenting options during the tendering process. Examples of successful collaborations include redesigning a carton to reduce its carbon footprint by 20% without additional costs and developing lighter primary packaging to save on plastic use and costs.

Industry Partnerships for Net-Zero Emissions

Partnerships among supply chain companies are essential to help the industry achieve net-zero emissions. The Alliance to Zero, founded in 2021 by eight pharmaceutical supply chain companies, is one such initiative. By sharing detailed product data, members like Sharp and Ypsomed have created a detailed carbon footprint for autoinjectors and are working together on carbon reduction strategies across the supply chain.

Regulatory Support for Sustainable Solutions

Achieving industry-wide sustainability transformations requires regulatory support. Woolf emphasized the need for leadership and regulatory changes to implement sustainable solutions proposed by pharmaceutical suppliers. This would encourage broader behavioral changes across the industry and the adoption of eco-friendly solutions, including design, material selection, and circularity, while maintaining patient safety as a priority.

Future Outlook

Looking forward, the pharmaceutical sector must navigate numerous challenges to achieve sustainability. The industry’s reliance on high-carbon materials and processes means that significant changes in design, sourcing, and production methods are necessary. However, with the right investments and regulatory support, these changes can lead to substantial environmental benefits and cost savings. By focusing on energy efficiency, sustainable sourcing, and eco-design principles, the pharmaceutical industry can make meaningful strides towards reducing its carbon footprint while meeting the growing global demand for medications.

Conclusion

The pharmaceutical industry happens to be at a critical juncture where the need for sustainability as well as the increasing demand for its products intersect. By way of energy efficiency improvements, sustainable sourcing programs along with the adoption of eco-design principles, the industry can go ahead and address these challenges and go ahead and move towards a more sustainable future. Partnerships along with the supply chain companies and support from regulatory bodies will be indeed essential in this journey. As the industry continues to go ahead and innovate and also evolve, the commitment to reducing emissions as well as promoting sustainability must remain right at the forefront of its efforts.

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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