喜报 | 海南中和药业零缺陷通过韩国(PIC/S) GMP官方检查

Zero Deficiency! Hainan Zhonghe Pharma Successfully Passes

Official South Korean (PIC/S) GMP Inspection

7月21至7月23日，韩国食品药品安全部 (Ministry of Food and Drug Safety, MFDS) 对我司展开 GMP现场检查。凭借扎实的生产管理体系、严谨的质量管控能力、规范的现场运维水准，该检查最终以零缺陷的优异成绩圆满通关，再次验证了公司国际化合规生产实力，为产品深耕韩国海外市场、持续稳定出口奠定了坚实的资质基础。

From July 21 to July 23, the Ministry of Food and Drug Safety (MFDS) of South Korea conducted an on-site GMP inspection of our company. Underpinned by the robust production management system, rigorous quality control capabilities, and high standards of on-site operations, we successfully passed the inspection with a “Zero Deficiency” rating. This achievement validates our international compliance and manufacturing strength once again, laying a solid qualification foundation for deepening our presence in the South Korean market and ensuring the continuous, stable export of our products.

韩国MFDS药监检查以法规标准严苛、细节核查细致、体系要求全面著称，是全球认可度极高的海外GMP审核体系。其检查条款覆盖生产过程、质量控制、仓储物流、文件追溯等全产业链环节，对企业的硬件设施、软件体系及人员素养均提出极高要求。正因如此，零缺陷通过MFDS检查，是企业合规实力的权威证明，充分展现了公司高效协作、严谨务实、精益求精的团队素养与企业风貌。不仅是对公司GMP合规体系、生产质量管控能力的权威认可，更是公司深耕国际化市场、坚持高标准质量管理的有力印证。

The MFDS inspection is renowned globally for its stringent regulatory standards, meticulous attention to detail, and comprehensive systemic requirements. It is one of the most highly recognized overseas GMP audit systems worldwide. The inspection criteria cover the entire industry chain, including production processes, quality control, warehousing， logistics, and document traceability, imposing exceptionally high demands on the hardware facilities, software systems, and personnel professionalism. Consequently, achieving a “Zero Deficiency” result in an MFDS inspection serves as authoritative proof of a company’s compliance capabilities. It fully demonstrates the team’s efficient collaboration, pragmatic approach, and commitment to excellence. This achievement not only represents recognition of the GMP compliance system and production quality control capabilities but also serves as strong testament to its dedication to deepening a presence in international markets and adhering to high-standard quality management.

征程不止，步履不停。韩国GMP检查的圆满收官，是阶段性成果，更是新一轮提升的起点。我司将以本次韩国检查圆满通关为契机，沉淀经验、固化成果、持续精进，将本次迎检积累的严谨作风、合规思维、精细化管理标准常态化落地。全体团队继续凝心聚力、整装再出发，以更扎实的功底、更严谨的态度、更高效的协作，持续夯实企业国际化合规竞争力，奋力书写公司海外市场高质量发展新篇章！

The journey continues without pause. The successful conclusion of the Korean GMP inspection is both a milestone achievement and a starting point for further improvement. Building on this successful inspection, our company will consolidate experience, institutionalize best practices, and strive for continuous improvement. We will normalize the rigorous work style, compliance mindset, and refined management standards developed during this process. Our team will remain united, ready to embark on the next phase with stronger expertise, a more rigorous attitude, and enhanced collaboration. We are committed to strengthening our international compliance competitiveness and striving to write a new chapter of high-quality development in our overseas markets.