昭衍（苏州）新药研究中心有限公司于2015年8月顺利通过OECD的 GLP认证检查，并于2017年8月4至9日接受OECD GLP的认证复查。该检查组来自于OECD成员国波兰国家GLP监管机构，他们代表OECD对昭衍（苏州）的组织机构及人员、SOP、供试品及档案管理、实验设施设备、实验实施过程、质量保证体系等进行了全面而细致的检查，并选取了多个遵从OECD GLP规范的专题进行了全面的溯源性检查。
此前一周，检查组专家还对昭衍（北京）进行了现场检查，并对昭衍（北京）设施和GLP法规依从性给予了高度评价。
昭衍（苏州）凭借昭衍良好的GLP工作基础，在过去的5年时间内，先后通过了国际AAALAC认证、中国GLP认证、OECD GLP认证、美国FDA的GLP现场检查以及其他多种法规检查和认证，具备全面支持全球药物注册的评价能力与资质，并与昭衍（北京）一起，已经为国内外委托方完成了数十个药物或生物产品向以美国FDA为主的国外药监机构提交了优质合规的非临床资料，并被全部接受和支持不同阶段的临床试验。至此，昭衍成为了国内资质最完备的非临床安全性评价机构。昭衍（苏州）和昭衍（北京）还将不断努力以提升质量管理水平和专题实验能力，为药物研发机构产品的全球注册提供更可靠和更方便的平台，支持和助推药物创新，为人类健康事业做出贡献。
JOINN granted Statement of Compliance for OECD GLP a second time
Officials from the Department for Good Laboratory Practice, Bureau for Chemical Substances of Poland have completed a second inspection and audit of JOINN facilities and studies. They have confirmed, once again, that the work of JOINN complies with the principles of OECD GLP.
The extensive audit process covered both of JOINN (Suzhou) and JOINN (Beijing), visiting all GLP areas of the company and reviewing data and procedures.
A spokesperson from JOINN said that audits such as this are always a good experience. Although we are so pleased to receive confirmation of our OECD GLP compliance standards, we are never complacent about what we do and always aim to further improve our compliance systems. We regard such independent audits as this as a learning exercise, and if they give us pointers to things that we might like to refine or change, that is absolutely great, she said.
JOINN will remain a member of the Polish monitoring authority’s GLP program.
