近日，欧盟EudraGMDP数据库更新了一则GMP检查不符合报告，其中提及HPLC 系统上的操作系统（Windows XP、Windows 7）过时的缺陷，此外还指出其未能实施欧盟 GMP 新版附录 1“无菌药品生产”的核心原则，包括场地设计、物料管理、无菌区域的人员行为、暴露表面的质量、人员培训等：

 

检查机构：西班牙药监局

 

被检查企业：Nectar Life Sciences Limited

 

最近一次检查：2025 年 2 月 11日

 

检查结论：不符合

 

During inspection, 28 deficiencies were identified, 4 of them has been classified as critical and 3 as major. The critical deficiencies are related to Quality Assurance management, aseptic operations in relation to compliance with Annex I of the GMP, maintenance and cleaning of equipment and facilities, and computerised systems. And the major deficiencies were observed in the areas to validation of analytical methods, staff training and batch release.

 

在检查过程中，发现了 28 项缺陷，其中 4 项被归类为严重缺陷，3 项被归类为主要缺陷。严重缺陷与质量保证管理、与 GMP 附录1 相关的无菌操作、设备和设施的维护和清洁以及计算机化系统有关。在分析方法验证、员工培训和批放行方面观察到了主要缺陷。

 

Since the deficiencies found transversally affect both the manufacturing of non-sterile APIs (some of whose manufacturing facilities were also inspected) as well as sterile API facilities, it has been decided to issue an statement of Non-compliance with GMP that affects both types of products.

 

由于发现的缺陷同时影响了非无菌 API 的生产（其中一些生产设施也接受了检查）和无菌API 设施，因此决定发布影响这两种类型的产品的不符合 GMP 声明。

 

The most relevant or critical deficiencies observed during the inspection are described below :

 

在检查期间观察到的缺陷描述如下：

 

- A number of severe violations of EU GMP Part II, EU GMP Annex 1 and Annex 11, potentially posing a risk to the quality of manufactured products and therefore to public health, demonstrated a lack of Quality Assurance oversight and understanding of core requirements.

 

-严重违反欧盟 GMP 第II 部分、欧盟 GMP 附录 1 和附录 11，可能对产品的质量构成风险，从而对公众健康构成风险，表明缺乏质量保证监督和对核心要求的理解。

 

- The company failed to implement core principles of EU GMP Annex 1 “Manufacture of Sterile Medicinal Products”. Consequently, the sterility of the Active Pharmaceutical Ingredients (API) manufactured in Block SE, Nectar Life Science Unit II, cannot be guaranteed, posing a risk to human and/or veterinary health. Abundant and important shortcomings were found among the site related to but not limited to site design, materials management, personnel behavior in aseptic areas, quality of exposed surfaces and failure to identify applicable requirements, risks and risk mitigation measures regarding revised Annex and general GMP requirements.

 

该公司未能实施欧盟 GMP 附录 1“无菌药品生产”的核心原则。因此，无法保证所生产的活性药物成分（API）的无菌性，导致对健康构成风险。在现场发现了大量重要的缺陷，包括但不限于场地设计、物料管理、无菌区域的人员行为、暴露表面的质量，以及未能确定与新修订GMP附录和一般 GMP 要求相关的要求、风险和风险缓解措施。

 

-There is a significant risk of contamination/cross contamination of non-sterile APIs/intermediates manufactured based on the cleaning and/or maintenance status of the facility and the equipment used. Several observations made during the inspection of Oral Block F conclude that the manufacturing facilities and equipment for active ingredients have not been adequately maintained over the years, resulting in a significant deterioration of their condition and therefore posing a risk to the quality of APIs and ultimately to the patient. These observations include lack of maintenance, cleaning, presence of corrosion, concrete cracks, signs of liquid leakages, lack of hand-washing facilities, and other significant signs of poor maintenance, management and hygiene.

 

根据设施和所用设备的清洁和/或维护状态进行生产的非无菌 API/中间体存在污染/交叉污染的重大风险。在检查期间进行的几次观察得出结论，活性成分的生产设施和设备多年来没有得到充分维护，导致其状况恶化，因此对API 的质量构成风险，并最终对患者构成风险。这些观察结果包括缺乏维护、清洁、腐蚀、混凝土裂缝、液体泄漏迹象、缺乏洗手设施以及其他维护、管理和卫生不良。

 

- Several potential breaches on data integrity were found. Main aspects related to computerised systems were not addressed. The firm failed to implement basic requirements with regard to computerised systems as outlined in EU GMP Annex 11 and EU GMP Part II section 5.4ff. The flaws detected could potentially lead to failures in analytical testing and/or breaches in data integrity. The following shortcomings, among others, were observed: outdated operating systems on HPLC systems (Windows XP, Windows 7), no traceability (e.g. audit trail) or approval of the change of some HPLC sequences, problems with operators’ privileges and lack of computerised systems validation.

 

发现了几个潜在的数据完整性漏洞。与计算机化系统相关的主要方面没有得到解决。该公司未能实施欧盟 GMP 附录 11 和欧盟 GMP 第II 部分第 5.4ff 节中概述的有关计算机化系统的基本要求。检测到的缺陷可能会导致分析测试失败和/或数据完整性违规。除其他外，观察到以下缺陷：HPLC 系统上的操作系统（Windows XP、Windows 7）过时，某些 HPLC 序列的更改没有可追溯性（例如审计追踪）或得到批准，操作人员权限问题以及缺乏计算机化系统验证。

 

- The Company also disregards pivotal aspects of GMP rules such as training (for instance, on the reviewed Annex I or failure to fulfill training requirements of the personnel), analytical method validation (not even planned to be done), or batch release verifications.

 

公司还无视 GMP 规则的关键方面，例如培训（例如，关于新版附录1 的培训或未能满足人员的培训要求）、分析方法验证（甚至没有计划进行）或批放行确认。

来源：Internet

关键词： GMP检查