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皓元医药:控股子公司重庆皓元通过欧盟QP审计
news flash· 2025-06-17 09:33
Core Viewpoint - The company has successfully passed the EU Quality Person audit, indicating that its subsidiary has met EU GMP standards for quality management and production capabilities [1] Group 1: Audit and Compliance - Chongqing Haoyuan has received a compliance audit report issued by the Qualified Person (QP) after a thorough audit covering quality management, production management, facilities, material systems, and packaging and labeling systems [1] - The audit assessed critical aspects such as sterility assurance, computerized systems, data integrity, quality management, and material management [1] Group 2: Organizational Readiness - Chongqing Haoyuan has established an organizational structure, personnel configuration, facilities, and procedures that comply with EU GMP requirements [1] - The successful QP audit signifies that the company's quality management system and production capacity are aligned with EU GMP standards, ensuring high-quality research and production of biopharmaceuticals [1] Group 3: Market Expansion - The achievement of passing the QP audit lays a foundation for the company to expand into domestic and international markets [1] - The successful audit is not expected to have a significant impact on the company's current performance [1]