2026年4月，奥地利药监局对生产API的中国四川药企Sichuan New Hawk Biotechnology Co. Ltd.进行了GMP检查，检查结束日期为4月24日，相关的GMP不合规报告于2026年7月3日公布在EudraGMDP数据库。
An on-site GMP inspection was carried out for the first time in April 2026 for the manufacturing of API Diosmin. This was an inspection carried out in frame of the EDQM´s inspection programme to assess the compliance with Part II EU GMP guidelines and the approved CEP dossier (CEP 2016-173). The inspectors identified 1 critical, 8 major, 17 other deficiencies and 4 CEP dossier / CEP holder responsibility violations.
2026年4月，首次对原料药地奥司明的生产进行了现场GMP检查。此次检查是欧洲药品质量管理局（EDQM）检查计划的一部分，旨在评估其是否符合欧盟GMP指南第二部分以及已批准的CEP文件（CEP 2016-173）的要求。检查人员共发现1项严重缺陷、8项主要缺陷、17项其他缺陷，以及4项CEP文件/CEP持有人责任方面的违规问题。
The critical finding was related to the validity and integrity of data generated in the QC laboratory using the HPLC system. Final release results for Diosmin API could not always be relied upon as the testing for related substances and assay was not always performed in accordance with the company’s internal method of analysis nor the CEP dossier. Specifically, system suitability and reference standard (a) injections were not included in the sequences for multiple batch analyses. Of the 30 batches released to Europe since the beginning of 2023, 24 batches had been tested without system suitability and reference standard (a) injections in the same sequence as the sample analysis. These analyses referenced system suitability and references standard injections from different sequences carried out either before (e.g. up to 14 days) or after (e.g. up to 12 days) the sample analysis. Therefore, the sequences from which this data was obtained could not be considered as valid to support product release. Significant gaps were identified in HPLC controls, including missing system suitability tests, absent or incomplete sample receipt logs, and lack of traceability for certain batches. Documentation did not support batch classification (e.g. R&D vs production), and duplicate analyses of the same batch lacked clear differentiation, creating a risk of sample mix-ups. Additionally, procedures for data backup were incomplete, and system access rights were not managed per SOP, with inappropriate privileges granted to the QP.
其中，严重缺陷涉及使用高效液相色谱（HPLC）系统在QC实验室生成的数据的有效性和完整性。由于有关物质和含量测定的检测未始终遵循公司内部分析方法或CEP文件的规定，因此地奥司明原料药的最终放行结果无法完全信赖。具体而言，在多个批次的分析序列中，未包含系统适用性测试及对照品（a）的进样。自2023年初以来，向欧洲放行的30个批次中，有24个批次在分析序列中未进行系统适用性测试和对照品（a）的进样。这些分析引用了在样品分析之前（例如，最多提前14天）或之后（例如，最多延迟12天）进行的不同批次的系统适用性测试和对照标准品进样数据。因此，获取该数据的分析批次无法被视为支持产品放行的有效依据。在高效液相色谱（HPLC）控制方面存在重大缺陷，包括缺少系统适用性测试、缺失或不完整的样品接收记录，以及部分批次缺乏可追溯性。文件资料未能支持批次分类（例如研发与生产批次），对同一批次的重复分析也缺乏明确区分，存在样品混淆的风险。此外，数据备份程序不完整，系统访问权限未按SOP进行管理，质量受权人（QP）被授予了不当的权限。
8 major deficiencies were identified related to rejection and re-use of materials and recovered materials, quality management, process equipment, documentation and records, production and in-process controls, packaging and labelling of APIs and intermediates and change control.
共发现8项主要缺陷，涉及物料和回收物料的拒收与再利用、质量管理、工艺设备、文件与记录、生产及过程控制、原料药和中间体的包装与标签，以及变更控制等方面。
最终该企业的CEP证书被暂停。
NMPA网站查询显示，该企业获得了《药品生产许可证》，发证日期为2025年3月27日，生产范围为原料药（地奥司明）（仅限注册申报使用）。
