（来源：昭衍JOINN）
转自：昭衍JOINN
2025年9月昭衍新药旗下两大药物安全性评价设施（昭衍（苏州）、昭衍（北京））先后经历了经济合作与发展组织（OECD）的GLP现场检查及复查，并于近日收到全面通过GLP认证的证书（该GLP证书覆盖领域包括药物、医疗器械、兽药、化学品等）。昭衍（苏州）自2015年首次通过OECD GLP认证后，已连续6次通过GLP资质复查；这是昭衍（北京）首次获得OECD GLP认证，昭衍新药的双设施自此同步持有OECD GLP资质。
此次检查由OECD成员国波兰的GLP监管机构执行。波兰是OECD MAD签约国，也是欧盟成员国，本次检查依据波兰、欧盟及OECD GLP规范的要求，全面验证了昭衍两地设施质量体系的合规性。昭衍（苏州）的复查重点聚焦在质量体系的持续合规性，通过现场检查核心模块运行状态、每个类型的研究专题全流程溯源核查，检查组确认研究机构的运行管理持续符合GLP规范要求。对于昭衍（北京），开展了全面核查，围绕实验设施管理、仪器设备管理、人员操作规范性、原始数据完整性、质量保证流程闭环管控等核心维度进行全面、深入和细致的审查，验证了昭衍（北京）的质量管理体系及运行完全符合OECD GLP规范的要求。
此次双设施同步通过OECD GLP检查，是对昭衍的质量体系及质量管理国际化的再一次确认，结合昭衍的中国GLP及美国FDA GLP资质，昭衍有能力为全球的药物创新提供支持，特别为中国药物创新走向世界提供坚实的药物安全性评价支撑！
JOINN (Beijing) & JOINN (Suzhou) Facilities Secure OECD GLP Certification & Re-certification, Mature Quality System Backs Pharma Innovation
2025.09.15 - 2025.09.22, the two core research facilities under JOINN Laboratories (China) Co., Ltd. — JOINN (Beijing) and JOINN (Suzhou) — completed on-site OECD GLP (Good Laboratory Practice) inspections and re-inspections in sequence. Both facilities recently received official certificates confirming they fully meet OECD GLP standards, which encompasses multiple fields, including pharmaceuticals, medical devices, veterinary drugs, chemical substances, and other relevant categories.
JOINN (Suzhou) first earned OECD GLP certification back in 2015, and has now passed GLP qualification re-inspections six times in a row. For JOINN (Beijing), this marks its debut OECD GLP certification — a milestone that means both of JOINN’s facilities now hold OECD GLP qualifications side by side.
The inspections were led by Poland’s GLP regulatory body. Poland is not only an OECD member, but also a signatory to the OECD Mutual Acceptance of Data (MAD) Agreement and an EU member state. Following Polish, EU, and OECD GLP rules, the inspections fully validated that the quality systems at both JOINN sites are up to code.
For JOINN (Suzhou), the re-inspection zeroed in on maintaining quality system compliance. Inspectors checked the operational status of core modules on-site and traced every step of each research project’s workflow. In the end, they confirmed the facility’s day-to-day operations and management consistently meet GLP requirements.
JOINN (Beijing) underwent a full-scale inspection, covering critical areas like lab facility management, equipment oversight, staff operational standards, raw data integrity, and closed-loop quality assurance controls. The in-depth, detail-focused review proved that JOINN (Beijing)’s quality management system — and how it’s run — fully aligns with OECD GLP rules.
Both facilities passing OECD GLP inspections at the same time reinforces that JOINN’s quality system and quality management practices meet global standards. With its existing China GLP and U.S. FDA GLP qualifications, JOINN is well-positioned to support pharmaceutical innovation worldwide — especially acting as a cornerstone for China’s pharma innovators looking to make their mark on the global stage, by providing reliable safety evaluation support.
昭衍新药（股份代码：603127.SH/6127.HK）是中国最早从事药物非临床评价的CRO企业，1995年成立至今，在北京、苏州、广州、上海、南宁、云南以及美国加州、波士顿设有子公司，拥有近2500人的专业技术团队，致力于提供专业的服务。昭衍新药拥有符合国际规范的质量管理体系（CNAS/ILAC-MRA认证），具备中国NMPA、美国FDA、经合组织OECD、韩国MFDS、日本PMDA的GLP资质以及国际AAALAC（动物福利）认证资质，评价资料满足全球药品注册要求。昭衍新药可以向客户提供非临床药理毒理学研究及评价，特别是非临床安全性评价，临床试验及药物警戒等一站式服务；还可以提供实验动物，模型动物，兽药、农药及医疗器械评价等服务项目。
Founded in 1995, JOINN Laboratories (China) Co., Ltd. (JOINN Laboratories, stock codes: 603127.SH / 6127.HK) is a specialized drug development outsourcing company (CRO). The company’s headquarters is located in Beijing, with subsidiaries in Suzhou, Guangzhou, Shanghai, Nanning, Yunnan, San Francisco and Boston. We boast a large-scale professional technical team committed to delivering exceptional services. JOINN Laboratories has established a quality management system that adheres to international standards (CNAS/ILAC-MRA certification) and holds GLP certifications from China’s NMPA, the US FDA, the OECD, Korea’s MFDS, and Japan’s PMDA. We are also accredited by AAALAC, ensuring that all evaluation materials meet global pharmaceutical registration requirements. Our company provides non-clinical pharmacology and toxicology research and evaluation services to global clients. We specialize in non-clinical safety evaluation, clinical trials, pharmacovigilance, and more. Additionally, we offer services such as experimental animals, disease model animals, and evaluations for veterinary drugs, pesticides, and medical devices.
At JOINN Laboratories, we uphold our mission: Serving Drug Innovation, Focusing on Safety Evaluation and Monitoring Throughout the Drug Lifecycle. Our ultimate goal is to ensure patient safety and protect human health.
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