At the invitation of EXCIPACT asbl, Kaixin Certification attended the China-region training meeting.

On September 3, 2025, the “EXCiPACT–IPEC China–SPPEA Joint Training Conference on Pharmaceutical Excipient GMP and Risk Assessment”, hosted by EXCiPACT asbl and co-organized by the International Pharmaceutical Excipients Council (China) and the Jiangsu Pharmaceutical Packaging and Excipients Association (SPPEA), was successfully held at the Xuanwu Hotel in Nanjing. Kaixin Certification was invited to attend the training conference.

At the conference, Iain Moore, Senior Advisor of EXCiPACT, delivered a comprehensive presentation covering the fundamentals of EXCiPACT GMP, as well as its establishment and revision processes. He also introduced EXCiPACT as an independent third-party certification scheme that places patient safety at its core and applies risk-based approaches across the entire supply chain, including GMP (incorporating the China NMPA GMP Appendix), GDP, and GWP. Through EXCiPACT certification, companies can provide users with annual evidence of GMP/GDP/GWP implementation, thereby enhancing mutual trust and reducing the burden of multiple audits. In addition, EXCiPACT’s independent oversight mechanism ensures the transparency and reliability of the certification process.

Alain Becart, Quality Manager of EXCiPACT, explained how EXCiPACT can be used as a supplier management tool for excipient manufacturers, with a focus on the application of EXCiPACT certification in supplier qualification. The certification process consists of two main steps: first, determining the required GMP level based on a formal risk assessment (FRA), classifying risks in accordance with relevant technical reports, and selecting an appropriate GMP system; second, completing the EXCiPACT qualification and certification.

Kaixin Certification’s participation in the “EXCiPACT–IPEC China–SPPEA Joint Training Conference on Pharmaceutical Excipient GMP and Risk Assessment” was a valuable learning and exchange experience, combining industry focus, technical depth, and practical relevance.

The expert interpretations of pharmaceutical excipient GMP standards provided at the conference closely aligned with current regulatory compliance requirements, enabling a clearer understanding of the key elements and execution details involved in effective implementation. The dedicated sessions on risk assessment, supported by practical case studies, offered a more systematic approach to risk identification, analysis, and control, highlighting the importance of dynamic and refined risk management throughout the entire excipient supply chain.

Through exchanges with industry peers, we gained insights into diverse compliance practices and risk-response strategies, while also experiencing the shared commitment of the pharmaceutical excipient industry to high-quality development. Looking ahead, Kaixin Certification will integrate the knowledge and insights gained from this conference into its certification practices, further enhancing its service capabilities in the pharmaceutical excipient sector. We also look forward to working closely with more industry partners to jointly promote the standardization of the pharmaceutical excipient industry, thereby strengthening the foundation for drug safety.