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陕西省药品监督管理局关于西安京西双鹤药业有限公司等药品生产企业药品GMP符合性检查结果的通告
Zhong Guo Zhi Liang Xin Wen Wang· 2025-09-28 09:11
Core Viewpoint - The article reports on the compliance inspection results of five pharmaceutical manufacturing companies in Xi'an, China, conducted by the Shaanxi Provincial Drug Supervision Administration, confirming their adherence to drug production quality management standards [2] Group 1: Company Inspection Results - Xi'an Jingxi Shuanghe Pharmaceutical Co., Ltd. passed the inspection for large-volume injection and washing agents, with the inspection conducted from July 7 to July 11, 2025 [2] - Shaanxi Jiuzhou Pharmaceutical Co., Ltd. passed the inspection for oral solid preparations, specifically Olaparib tablets (150mg), from August 5 to August 8, 2025 [2] - Xi'an Yuanda Detian Pharmaceutical Co., Ltd. passed the inspection for lyophilized powder injections and entrusted production of injection use Yanhuning, from July 15 to July 18, 2025 [2] - Xi'an Hanfeng Pharmaceutical Co., Ltd. passed the inspection for tablets and hard capsules, with the inspection date on September 23, 2025 [2] Group 2: Inspection Scope and Compliance - The inspections covered various production lines and workshops, ensuring compliance with the Drug Production Quality Management Standards [2] - The inspections were conducted in accordance with multiple regulatory frameworks, including the Drug Administration Law and related management measures [2]
江西省药品生产监督检查结果公告(2025年第1号)
Zhong Guo Zhi Liang Xin Wen Wang· 2025-07-25 07:57
Core Viewpoint - The article discusses the results of drug production supervision inspections conducted by the Jiangxi Provincial Drug Supervision Administration from January to June 2025, highlighting compliance and non-compliance among various pharmaceutical companies [2][3][4]. Summary by Category Inspection Results - A total of 23 pharmaceutical companies were inspected during the first half of 2025, with most companies found to be compliant with the Good Manufacturing Practice (GMP) standards [2][3]. - Specific companies such as Jiangxi Ma Kang Pharmaceutical Co., Ltd. and Jiangxi Chengzhi Yongfeng Pharmaceutical Co., Ltd. were noted for their compliance in producing various drug forms including eye drops and traditional Chinese medicine [2][3]. Compliance Details - Companies like Jiangxi Qinfeng Pharmaceutical Co., Ltd. and Jiangxi Yichuan Pharmaceutical Technology Co., Ltd. were recognized for their adherence to GMP during inspections, covering a range of products from small volume injections to tablets [3][4]. - The inspections included checks on production lines for specific drugs, ensuring that companies met the required safety and quality standards [2][3]. Non-Compliance Issues - Some companies faced issues during inspections, although the article primarily focuses on those that complied with regulations [2][3]. - The inspections aimed to ensure that all pharmaceutical products manufactured in the province meet the necessary legal and quality standards [2][3][4].