博腾股份(300363.SZ)：子公司通过欧盟QP审计

Core Viewpoint - Boteng Co., Ltd. has successfully passed the EU Qualified Person (QP) audit, indicating that its quality management system meets EU GMP standards and can provide international standard formulation development and production services to global clients [1] Group 1: Audit and Compliance - Boteng Pharmaceuticals, a wholly-owned subsidiary of Boteng Co., Ltd., received a compliance statement from the EU Qualified Person [1] - The audit was conducted based on EU GMP Guidelines EudraLex Volume 4, EU Clinical Trial Regulation (536/2014), and GMP for IMP guidelines [1] - The audit scope included quality management, production management, facilities, material systems, and packaging and labeling systems for injectable, oral solid, and non-sterile semi-solid formulations [1] Group 2: Implications for Business - The successful QP audit signifies that Boteng Pharmaceuticals can now offer customized formulation development and production services that comply with international standards [1]