本期文章介绍一下2025年12月16日公布的EMA GMP不合规报告。本次被检查的对象为捷克的Fagofarma s.r.o.，检查的范围包括生物发酵工艺生产的活性物质以及非无菌和无菌临床实验药品。检查结束日期为2025年11月12日。以下是缺陷的详细内容：
The inspection team identified a total of 25 deficiencies: three classified as critical, 17 as major and 5 as minor. Two critical deficiencies concerned the implementation of the pharmaceutical quality system and the knowledge, experience, and number of qualified personnel. The third critical deficiency related to the certification of manufactured preparations and the maintenance of a register of manufactured and certified batches. The principal deficiencies across most areas of GMP involved missing or inadequate records of deviation investigations, change management, training, validation and qualification, documentation management, risk assessment, and stability studies. Critical deficiencies:
检查小组共发现25项缺陷：其中3项为严重缺陷，17项为重大缺陷，5项为微小缺陷。其中2项严重缺陷涉及药品质量体系的实施以及相关人员的知识、经验和数量，第3项严重缺陷与成品制剂的认证以及成品和认证批次的登记工作有关。GMP领域的主要缺陷包括缺失或不完整的偏差调查记录、变更管理记录、培训记录、验证和确认记录、文件管理记录、风险评估记录以及稳定性研究记录。严重缺陷如下：
1: The pharmaceutical quality system, including good manufacturing practice, is not functional. The system has not been implemented and properly documented, and the monitoring of its effectiveness is not based on real data and quality risk management. Records were either missing or incorrect.
药品质量体系（包括GMP）未能正常运行。该体系未得到实施且未进行妥善记录，对其有效性的监督也并非基于真实数据和质量风险管理。相关记录要么缺失，要么存在错误。
2: The company employs six staff workers. Since the last inspection, three personal changes have occurred in the area of plant management and quality assurance. New employees, in some areas, do not have sufficient knowledge and experience to perform and supervise the relevant activities.
该公司共有6名员工。自上次检查以来，在工厂管理及质量保证方面出现了3项人员变动。在某些领域，新入职的员工缺乏必要的知识和经验，无法独立执行和监督相关工作。
3: The register of manufactured batches is maintained only in an Excel spreadsheet. The inspected entity failed to provide evidence of certification of several batches by a Qualified Person.
生产批次的登记信息仅以电子表格的形式保存。被检查的实体未能提供由具备资质人员对若干批次产品进行认证的相关证明。
最终，该企业的药品被禁止上市，并建议暂停临床试验。
看到“该公司共有六名员工”时，博主是不太相信的，毕竟涉及生物发酵的生产操作。实在想不明白，这家药品生产企业是怎么仅靠6名人员就能维持下去的。但是缺陷总结处也提到人员数量存在不足，所以看来6名员工的数据是准确的。但即使不填写各种记录，6个人是怎么把生产的活儿都干了的？着实让人佩服。大家都自称牛马，这6个人简直是牛马中的牛马。可能的解释之一就是产能不饱和，生产批次数量有限。不过话又说回来，上次官方检查已经发现员工这么少，为何不取消其GMP证书？
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