The ISPE China GEP Practice Community has been officially established, ushering in a new chapter of excellence in pharmaceutical engineering.

The ISPE China GEP Practice Community has been officially established, ushering in a new chapter of excellence in pharmaceutical engineering.

— Empowering local pharmaceutical companies, the ISPE China GEP Practice Community has been established to support compliance and efficiency improvements in engineering.

[Shanghai, China, August 18, 2025] – The International Society for Pharmaceutical Engineering (ISPE) China has officially established the Good Engineering Practice (GEP) Community of Practice (CoP). This milestone marks an important step forward in advancing pharmaceutical engineering innovation and compliance in China, while further strengthening the country’s growing leadership in the global pharmaceutical engineering field.

To celebrate this milestone, the ISPE Shanghai Representative Office held a grand plaque-awarding ceremony, officially marking the launch of the ISPE China GEP CoP. Ms. Cathy Cao, ISPE China Operations Director, and Mr. Fuchang Yang, Chair of the CoP, presented certificates and plaques to the core leadership team, expressing gratitude for the selfless contributions of Chinese experts to the industry’s development and sharing high expectations for the future of the CoP. The ceremony not only reflected anticipation for the CoP’s upcoming work but also underscored ISPE’s firm commitment to advancing excellence in China’s pharmaceutical engineering.

Background of Establishment: Confronting Industry Challenges and Seizing Development Opportunities

In recent years, factors such as the global economic downturn, sluggish progress in innovative drug R&D and approvals, the continuous acquisition of domestic biotech firms by multinational pharmaceutical companies, and capital shortages in the secondary market have led to weak investment in pharmaceutical R&D and manufacturing. At the same time, however, China’s bio-pharmaceutical industry has made remarkable achievements in bringing innovative drugs to international markets. Domestic market returns have increased, and centralized procurement policies have shifted from a sole focus on low-cost bidding toward more rational value-based assessments. In addition, domestic pharmaceutical equipment and engineering capabilities have been developing rapidly, with a promising outlook for the future.
Against this backdrop, the establishment of the ISPE China GEP CoP is both timely and significant. It aims to help the industry confront challenges, seize opportunities, and enhance overall competitiveness.

Mission and Value: Proactive Leadership in a Multi-Dimensional Landscape

The key pain points in today’s pharmaceutical industry stem from market shifts, essentially reflecting a multi-dimensional challenge involving efficiency, quality, compliance, and innovation. The core mission of the ISPE China GEP CoP is to help pharmaceutical companies move from passive adaptation to proactive leadership at the forefront of the industry by delivering the following core values:

Standardized Engineering Practices: The CoP will work to develop standardized tools widely applicable across the industry, such as a modular information library for bio-pharmaceutical cleanroom design, in order to enhance project efficiency and quality.

Cross-Sector Resource Integration: The CoP will establish a collaborative platform linking government, industry, and academia to promote the application and transformation of cutting-edge technologies—such as artificial intelligence and digitalization—thereby accelerating innovation.

Lifecycle Management Tools: By focusing on lifecycle management, the CoP will advance the adoption of digital and AI-driven tools to help enterprises build sustainable, world-class competitive advantages amid policy changes, technological waves, and global competition.

Core Team and Future Outlook

The core leadership of the ISPE China GEP CoP is composed of top industry experts who will collectively provide strategic guidance to ensure the CoP effectively serves the needs of the pharmaceutical sector. The CoP is chaired by Mr. Fuchang Yang, with Mr. Yuchun Gu, Mr. Jingping Xu, Mr. Xin Xu, Mr. Jian Ye, Ms. Lin Zhang, Mr. Yang Zhao, and Mr. Miao Zhu serving as vice chairs, forming a strong and capable leadership team.

Chairman Fuchang Yang stated, ‘We are honored to establish the GEP Community of Practice. As a bridge connecting ISPE’s global resources with local practices, the ISPE China GEP CoP is committed to working with industry colleagues to drive innovation and compliance in pharmaceutical engineering, contributing to the healthy and sustainable development of China’s pharmaceutical industry.

The ISPE China GEP CoP warmly invites professionals, companies, regulatory bodies, and academia in the pharmaceutical industry to join in building an open and collaborative technical community. Together, we aim to explore the future of pharmaceutical engineering and establish a platform of excellence in the field.

About the International Society for Pharmaceutical Engineering (ISPE)

The International Society for Pharmaceutical Engineering (ISPE) is a global, non-profit professional organization. Its mission is to serve its members in the pharmaceutical field by leading advancements in science, technology, and regulatory practices across the entire pharmaceutical lifecycle. ISPE is committed to enhancing members’ knowledge and technical efficiency through forums that facilitate the exchange of academic ideas and practical experiences. It enjoys significant academic authority and influence in the global pharmaceutical engineering field and has been repeatedly invited to participate in the development and discussion of regulatory guidelines by the U.S. Food and Drug Administration (FDA) concerning pharmaceutical engineering.

Under the guidance and support of the Shanghai Municipal Science and Technology Commission, ISPE’s ISPE Shanghai Representative Office conducts academic exchange activities between China and abroad in the pharmaceutical industry. These initiatives strengthen collaboration and dialogue between ISPE’s global pharmaceutical engineering professionals and Chinese pharmaceutical companies, regulatory authorities, universities, and research institutions. The office supports bio-pharmaceutical technology and industrial innovation in China, particularly in Shanghai, and provides solutions to the complex challenges faced by the pharmaceutical industry.