OUTSOURCING SUPPLY OPERATIONS


where manpower may be limited, Broyles stated.


Disparity between industry sentiment and actions While sustainability was an underlying theme discussed across multiple panels and presentations in last year’s CPHI Europe conference, a consensus on achieving it was lacking. According to a report by Doug Nissinoff, Senior Research and Strategy Associate at BioPlan Associates Inc, which was included in CPHI’s Annual Industry Report, while the industry shows “a notable inclination toward eco-friendly and sustainable solutions, the existing infrastructure and operations contradict these aspirations”. Data included in CPHI’s Annual Industry


Report reveals a “concerning reliance on less sustainable methods: for instance, a staggering 40.7% of facilities resort to incineration of medical waste, despite only 18.5% of respondents seeing this as an ideal practice”. Additional data from the report reveals that even though there is an “overwhelming sentiment favoring the recycling of single-use devices by sending them back to manufacturers – nearly half of the respondents (48.1%) believe this should be the norm – yet a meager 4.9% of facilities implement such practices.” Such divergence between the industry’s expressed notions and actual implementation of sustainable solutions highlights a need for further action. A true transformation towards sustainability


requires a mindset and organisational change, as well as for revenues and economic incentives to be dependent on sustainable initiatives, based on CPHI’s report. According to Nissinoff, “while awareness of sustainable disposal methods is present, systemic changes and infrastructure investments are imperative to bridge the existing chasm and align actual practices with the collective vision for a greener biopharmaceutical future.”


Stricter supplier assessment is critical On the topic of ingredient quality, all experts expressed a deep concern for the potential product safety and efficacy risks associated with diversity among suppliers and their significant impact on patients’ lives. During the


12 | Clinical Trial Supply Handbook


panel discussion, Broyles challenged the notion that all suppliers/vendors are equal in terms of substance quality, emphasising the need for robust supplier qualification programs across different vendors and even across one vendor supplying multiple different substances. Broyles stressed the importance of thorough qualification beyond a checkbox process, with a call for critical conversations within companies to establish the necessity of scrutinising suppliers even within the same window of materials. Additionally, the panel speakers considered the complexities in the excipients industry, where variations in raw material sources can impact product quality, which is more relevant than ever due to sociopolitical challenges in certain regions. The panelists focused on the need for a


nuanced approach to supplier qualification, considering specific company and product requirements and potential variations in the supply chain. More specifically, Broyles emphasised the importance of addressing problems upstream in the supply chain through measures like strict vendor assessment, routine audits, and asking the right questions to ensure the quality of ingredients. She cautioned against overly attractive deals, stating that “if something seems too good to be true, it probably is.” She also stressed that the responsibility lies with pharmaceutical companies to secure their supply chains, remove rogue suppliers, maintain stringent supplier qualification processes, and follow regulations and guidelines meticulously, citing instances where failure to do so has resulted in FDA warning letters. However, high quality product standards


dictated by regulatory bodies may hinder sustainability efforts in some cases. According to CPHI’s annual industry report, “the FDA and EMA have set the standard for product quality and this makes sustainability initiatives difficult to implement.” In some instances, there is a critical question of whether a company is willing to risk sacrificing product efficacy by switching reagents to achieve greener formulations. While sustainability initiatives can limit resource consumption and increase profitability, “demonstrating a return on investment (ROI)” and “convincing boards to invest in sustainability initiatives” make this challenging, according to the CPHI report.


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