#Japan #Tokyo #GMP #Hitachi #HITPHAMS

Hitachi Unveils Pharmaceutical Manufacturing Platform

In July 2023, Hitachi Ltd. and Hitachi Industrial Control Solutions began offering a groundbreaking new platform geared toward the pharmaceutical sector, specifically focusing on Good Manufacturing Practice (GMP) compliance. As the global pharmaceutical manufacturing market is expected to grow at an annual rate of 17%, reaching a staggering market size of 120 trillion yen by 2030, the need for effective digital transformation is becoming increasingly critical. The newly launched platform addresses two pressing challenges: stricter regulatory compliance and severe labor shortages within the industry.

The platform enables the centralized management of various manufacturing, testing, and quality-related data, effectively combatting the data silos that have plagued the industry. By leveraging technologies such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Quality Management Systems (QMS), the data can be accessed and utilized holistically. Furthermore, the implementation of generative AI enhances quality assurance processes while streamlining manufacturing operations for increased efficiency.

The initial features of the platform include support for crucial GMP-related tasks such as Annual Product Review, deviation investigations, and audit compliance — activities that traditionally require vast amounts of time and manual effort. Future development plans outline further enhancements, including AI-driven analysis of images and videos to automatically detect work deficiencies, digitalization of procedures, and real-time feedback from onsite data that enables autonomous optimization of equipment operates.

Moreover, leveraging its extensive expertise in regulatory compliance and integrating IT and Operational Technology (OT), Hitachi aims to develop this platform progressively into a comprehensive data integration backbone for the entire pharmaceutical value chain — covering everything from drug discovery to clinical trials, manufacturing, and distribution. This will culminate in what is termed the Pharmaceutical DX Platform, which will incorporate advanced AI with digitized assets and domain knowledge, forming the next-gen solution suite known as HMAX Industry.

Addressing Current Challenges in Pharmaceutical Manufacturing

The pressing demand for operational efficiency driven by digital transformation in pharmaceutical manufacturing is countered by the massive barriers posed by stringent GMP practices. Currently, the fragmented nature of MES, LIMS, and QMS systems means that employees are often burdened with labor-intensive data verification and cross-referencing. This fragmentation is particularly problematic when investigating deviations, as teams frequently waste significant hours tracking down historical data across multiple systems. The pressure to maintain high levels of accuracy raises the risk of human error, which can have dire consequences on both compliance and operational efficiency.

Hitachi Industrial Control Solutions has developed this innovative platform to address such fragmentation and alleviate the excess burdens on employees involved in GMP operations. By centralizing data and pairing it with AI technology, the platform aims to significantly mitigate risks and foster an efficient digital transformation in manufacturing practices.

Hitachi Group's stronghold in the pharmaceutical domain is highlighted by its rich experience in delivering a suite of IT and OT products, including HITPHAMS, a leading pharmaceutical manufacturing and quality management system in the domestic market. The insights gained from years of involvement in pharmaceutical manufacturing underpinned the development of this pioneering platform.

Future Steps: Expanding into the Entire Pharmaceutical Value Chain

Looking forward, Hitachi intends to leverage its stringent regulatory expertise in a phased rollout of the Pharmaceutical DX Platform that connects drug discovery to manufacturing and distribution. The journey begins with implementing core features in the manufacturing arena, with plans to foster the seamless sharing of foundational research data and trial results back to the manufacturing floor. This will not only expedite the scaling up of production but also contribute significantly to continuous improvements in quality and deviation prevention, maximizing the overall value of the value chain.

Additionally, Hitachi is actively focusing on HMAX Industry, a next-generation solution set combining domain knowledge and advanced AI with data from its extensive installation base (digitized assets). Through the core offerings of its Industrial Solutions, Hitachi aims to maximize customer lifetime value while effecting transformational change across industries, all while working toward a more prosperous society.

For more details about the Pharmaceutical Manufacturing Platform, visit Hitachi GMP Platform and for HITPHAMS, check out HITPHAMS.