From May 26th to 27th, the China Annual Conference of the International Society for Pharmaceutical Engineering (ISPE) was grandly held in Shanghai. With the purpose of “Pooling Global Leading Wisdom to Empower Chinese Pharmaceutical Industry”, this grand event attracted leading figures in the industry from home and abroad to jointly discuss the cutting-edge and future trends of the pharmaceutical industry and inject impetus into industrial upgrading. Mr. Paul Dong, CEO of Wellthinic Technology, and Ms. Lucy Xi, Deputy General Manager and Digitalization Technology Director, attended the conference. As a representative of Zhejiang Pharmaceutical Industry Design Institute and Wellthinic Technology, Ms. Lucy Xi delivered a speech at the forum.

Centering on the core topic of the digital and intelligent transformation of the pharmaceutical industry, she started from the opportunities and challenges faced by the industry's development, profoundly analyzed the importance of digital and intelligent transformation for pharmaceutical enterprises. She not only elaborated in details on how core technologies such as the integration of automation and digitalization can be applied in scenarios of pharmaceutical production and quality safety assurance, but also, by combining the practical experience of typical projects such as the construction of new digital factories for domestic blood products and the digital and intelligent global production of multinational pharmaceutical companies, vividly demonstrated the remarkable results brought by digital and intelligent transformation in aspects such as material management and control, quality assurance, and compliance of electronic batch records, opening up new ideas and providing new solutions for the pharmaceutical industry on the path of compliance upgrading.

Currently, the pharmaceutical industry is at a crucial juncture of transformation. The regulatory system is accelerating its alignment with international standards, and strict regulatory requirements are gradually incorporating electronic records into key regulatory scopes. The demand for innovative drugs is surging, placing higher demands on the level of production automation. The overseas expansion of innovative drugs holds great potential, prompting enterprises to actively build global R&D, supply chain, and quality management systems based on digitalization, as well as overseas localized operation capabilities, to enhance international competitiveness.

In this complex industry situation, the digital and intelligent transformation of the pharmaceutical industry has become an inevitable path for industrial upgrading. The state has also successively introduced a number of regulations and policies to safeguard the industry's transformation.

In the application scenarios of pharmaceutical production and quality assurance, digital and intelligent technologies demonstrate a strong enabling effect. Transparent production, leveraging advanced data collection and intelligent analysis technologies, can conduct real-time and accurate monitoring of production progress, inventory status, and equipment operation, and achieve scientific production scheduling. Material management realizes the refined control and accurate traceability of the entire life cycle from the warehousing, requisition, to consumption of raw and auxiliary materials. Formula and process flow management ensure the standardization and harmonization of the production process, effectively improving the first-pass yield of products. Quality management, by strengthening the traceability capability throughout the production process, significantly enhances the efficiency of batch record review and release. The Manufacturing Execution System (MES), Laboratory Information Management System (LIMS), Supervisory Control and Data Acquisition (SCADA) work closely in coordination with the Enterprise Resource Planning (ERP), Warehouse Management System (WMS), Quality Management System (QMS) and other systems, jointly building an efficiently operating digital and intelligent ecosystem.

From the perspective of practical project implementation, the remarkable value of technology integrating automation and digitization has been fully verified. The MES system enables automatic data collection throughout the entire production process and automatically generates compliant electronic batch records, meeting regulatory requirements for data integrity. The system automatically splits and dispatch production orders, brings manual inspection and material dispense processes into the scope of process control, and deeply interacts with the core production process automation control system to form a truly closed-loop management. This innovative model not only ensures production compliance but also significantly improves overall operational efficiency.

The company is committed to refining its rich practical experience into standardized solutions and promoting the establishment of industry standards for digital-intelligent applications. By constructing a complete standard system covering digital-intelligent blueprint planning, application scenario design, implementation process specifications, and validation protocols, as well as developing advanced digital-intelligent software platforms, it provides pharmaceutical enterprises with one-stop professional services ranging from planning and design, project implementation to compliance consulting. With its mature resource integration capabilities and professional service system, Wellthinic Technology ensures that each project not only meets the highest industry standards but also precisely matches the actual needs of enterprises. Wellthinic Technology looks forward to joining hands with more industry partners, gathering innovative forces, and jointly promoting the digital-intelligent process of the pharmaceutical industry, striding steadily towards the grand goal of "Smart Manufacturing for the Future".