（来源：中国医药报） 转自：中国医药报 生产管理的目的是采取有效措施，最大限度地降低药品生产过程中混淆、差错、污染和交叉污染等风 险。药品商业生产阶段质量管理的目的是对药品的工艺性能和产品质量进行监测，确保生产工艺处于一 个稳定、可控的状态并持续进行改进。 追溯管理 新修订《中华人民共和国药品管理法》对药品研制、生产、经营、使用活动中信息的真实、准确、完整 和可追溯提出了明确要求。 追溯性是医药企业质量管理方式的一种体现形式。从物料进厂至产品出厂的每个环节，物料、中间产 品、成品均有唯一的身份标识，以实现产品生命周期内的有效追溯。产品生产过程中追溯性的建立，通 常采用的方式是批号管理。结合制药行业信息化的实施，信息化系统的应用同样也是依赖于生产不同阶 段输入物及产出物的唯一身份（条码或批号）标识进行识别及管理。批号的"唯一性"至关重要。标识是 企业建立药品生产过程中追溯性的一种有效方式。生产过程中设备、物料的正确标识也是一种有效降低 生产过程中出现差错和混淆的控制手段。 制等相关的产品进行注册批准后的变更，企业均应根据相关产品批准后变更指导原则实施。 此外，文件和记录的可追溯性也很重要。药品生产过程中各类操作 ...

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., has successfully passed an FDA inspection, confirming compliance with CGMP standards for its production facility [2]. Group 1 - The FDA conducted an on-site inspection from August 18 to August 22, 2025, focusing on the overall quality management system and oral solid dosage products of Huahai Technology [2]. - The inspection report indicates that Huahai Technology's production base meets the requirements of current Good Manufacturing Practice (CGMP) for pharmaceuticals [2].

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., Ltd., successfully passed an FDA inspection, confirming compliance with current Good Manufacturing Practices (CGMP) for drug production [1] Group 1 - The FDA inspection took place from August 18 to August 22, 2025, covering the overall quality management system and oral solid dosage products of the factory [1] - The inspection report indicates that the production base of Huahai Technology meets the requirements of CGMP [1]

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., Ltd., successfully passed the FDA's on-site inspection, confirming compliance with current Good Manufacturing Practices (CGMP) for drug production [1] Group 1 - The FDA inspection took place from August 18 to August 22, 2025, covering the overall quality management system and oral solid dosage products of the factory [1] - The inspection report indicates that the production base of Huahai Technology meets the requirements of CGMP [1]

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Pharmaceutical Technology Co., Ltd., successfully passed an FDA inspection, confirming compliance with current Good Manufacturing Practices (CGMP) for drug production [1] Group 1 - The FDA inspection took place from August 18 to August 22, 2025, covering the overall quality management system and oral solid dosage products of Huahai Technology [1] - The inspection report indicates that the production base of Huahai Technology meets the requirements of CGMP [1]