Howlett Michael, Niarchou Eleni, Naughton Bernard D
The School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, The University of Dublin, Dublin, Ireland.
Centre for Pharmaceutical Medicine Research, School of Cancer & Pharmaceutical Sciences, King's College London, London, UK.
J Med Access. 2024 May 23;8:27550834241250279. doi: 10.1177/27550834241250279. eCollection 2024 Jan-Dec.
Just in Time (JIT) and Lean manufacturing are concepts that originated in the automotive industry and were then adopted by pharmaceutical and biopharmaceutical companies during the 1990s. However, the Covid-19 pandemic and the urgent demand for pharmaceutical treatment challenged JIT and Lean manufacturing processes. Production of Covid-19-related medicines increased, putting pressure on global supply chains and operations. This also hindered the production of medicines using the same or similar materials. Thus, questions are raised concerning JIT and Lean supply chains in the pharmaceutical industry.
The present study aimed to explore (1) if material and supply constraints occurred due to the Covid-19 pandemic, (2) how companies were impacted and managed and (3) if changes are required to future proof the JIT supply chain approach for future global events.
A mixed-method cross-sectional survey design was used and focused on material supply, qualification and validation in Irish pharmaceutical manufacturing sites.
Employees working in the Irish pharmaceutical manufacturing industry were recruited using convenience sampling through online advertisement using the social media platform 'LinkedIn'. Quantitative data was analysed using percentages and qualitative data from free-text responses were used to add context to the quantitative survey questions.
A total of 41 participants were recruited. The results suggested that the pandemic had a negative effect on material availability according to 81% of participants. This translated to delays or stoppage of production activity and was mainly handled by sourcing new materials (70%). To cope with future global crises, 60% of participants recommended more flexibility in future validation processes while 78% of participants acknowledged the importance of validating additional suppliers. A hybrid model of manufacturing and supply chain management was also a preferred approach to exclusive Lean and JIT (42%).
The production of non-Covid-19 medicines was adversely affected by the Covid-19 pandemic, but the pharmaceutical industry in Ireland demonstrated resilience and collaboration in response to these challenges. This study suggests that the JIT and Lean manufacturing model should be adjusted to ensure medicine supply chains are not disrupted during future global events.
准时制(JIT)和精益制造是起源于汽车行业的概念,在20世纪90年代被制药和生物制药公司采用。然而,新冠疫情以及对药物治疗的迫切需求对准时制和精益制造流程构成了挑战。与新冠相关药物的产量增加,给全球供应链和运营带来压力。这也阻碍了使用相同或类似材料的药物生产。因此,制药行业的准时制和精益供应链引发了诸多问题。
本研究旨在探讨(1)新冠疫情是否导致了材料和供应限制,(2)公司受到了怎样的影响以及如何应对,(3)是否需要做出改变以使准时制供应链方法能够应对未来全球事件。
采用混合方法横断面调查设计,重点关注爱尔兰制药生产基地的材料供应、资质认证和验证。
通过在社交媒体平台“领英”上发布在线广告,采用便利抽样的方式招募爱尔兰制药行业的员工。定量数据采用百分比进行分析,自由文本回复中的定性数据用于为定量调查问题增添背景信息。
共招募了41名参与者。结果显示,81%的参与者认为疫情对材料供应产生了负面影响。这导致生产活动延迟或停止,主要通过采购新材料来解决(70%)。为应对未来全球危机,60%的参与者建议在未来验证流程中增加灵活性,78%的参与者承认验证更多供应商的重要性。制造与供应链管理的混合模式也是比单纯的精益和准时制更受欢迎的方法(42%)。
新冠疫情对非新冠药物的生产产生了不利影响,但爱尔兰制药行业在应对这些挑战时展现出了韧性和协作精神。本研究表明,应调整准时制和精益制造模式,以确保未来全球事件期间药品供应链不受干扰。