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Good Engineering Practice - Investment Management
The presentation focuses on the intersection between Annex 1 and Pharma 4.0, with a specific emphasis on the innovative Takeda Linz beePFS project. It will begin with an introduction to Takeda and its Linz production site, highlighting the company's values and unique beehive culture. The overview will explain how these values influence the beePFS project, a high-speed initiative aimed at implementing a prefilled syringe filling line to reduce process performance qualification time to 24 months, while incorporating aspects of Pharma 4.0 and updated Annex 1 guidelines. The objective of the beePFS project is to enhance syringe supply security with a dual-source strategy, enabling larger quantities to be supplied quickly and adding in-house syringe filling capabilities to Takeda's aseptic network. The presentation will explore how the updates to Annex 1 and Pharma 4.0 principles impact pharmaceutical manufacturing, showcasing the transformative potential of the beePFS project as a pioneering innovation in the industry. It will address the challenges of integrating new requirements and technologies, the decision-making process for technology selection, and how Takeda leveraged the concept of Pharma 4.0 to ensure a lean, compliant production process within a fast-tracked project timeline.
The case study features detailed hazard screening of an RABS filling line, which uncovered critical process improvements previously overlooked, resulting in a significantly safer operation. The insights gained also facilitated the technology transfer to state-of-the-art equipment, integrating Quality by Design (QbD) and Quality Risk Management (QRM) principles. A key highlight of the study is the implementation of a fully integrated QRM approach. Utilizing AI, this approach automatically generated essential manufacturing documents - such as MBR, SOPs, training materials, and process overviews - directly from the risk profiling repository. This automation enabled shop floor personnel to manage residual risks more effectively and was supported by a comprehensive surveillance program.
The pharmaceutical industry faces significant challenges in fast expanding production capacity to respond to the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to respond to the dynamic demands of modern healthcare. This paper proposes a novel regulatory framework for Distributed Manufacturing that leverages the concept of "Fleet Management" to address these challenges. Fleet Management involves creating a network of standardized manufacturing facilities that can be efficiently managed and replicated across multiple sites. This approach draws inspiration from the principles of standardization that revolutionized other industries such as automotive manufacturing.
The proposed approach offers significant benefits, including improved regulatory efficiency, reduced drug shortages, and enhanced environmental sustainability. The paper calls for collaboration between regulators and industry stakeholders to refine and implement this innovative framework, paving the way for a more resilient and responsive pharmaceutical manufacturing ecosystem.
In today's fast-paced, resource-constrained industrial environment, the challenge of balancing innovation, operational excellence, and financial prudence is more critical than ever. The efficient management of Capital Expenditure (CAPEX) is essential to the long-term sustainability and growth of pharmaceutical manufacturing and other highly regulated industries.
This presentation will explore the critical role that Good Engineering Practices (GEP) play in ensuring that investments in physical assets - such as manufacturing equipment and facilities - are optimized through robust governance structures, clear processes, and alignment with strategic goals. The process of CAPEX management, from initial project identification to final approval and post-implementation review, will be dissected, with particular focus on:
- Governance and Stakeholder Management: Ensuring that the end-to-end CAPEX process meets the needs of key stakeholders such as project sponsors, financial controllers, and resource managers.
- Project Prioritization and Approval: Outlining the criteria for project selection, approval, and the role of Investment Committees.
- Risk Mitigation and Supporting Rational: to ensure effective prioritization, approval and implementation, optimization of return on investment
- Efficient Reporting: Utilizing digital platforms for efficient CAPEX tracking, forecasting, and reporting; maintaining regular financial updates enabling accurate forecasting, tracking, and cash flow control.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.