EMA不合规报告：Glukem Biocare流化床包衣设备污染风险列为关键缺陷，另有11项主要缺陷
EMA不合规报告：设备风道设计引发的关键缺陷
马耳他药监局于2026年9月15日结束对印度Glukem Biocare Private Limited的GMP检查，相关不合规报告于2026年10月16日在EudraGMDP数据库公布。
报告记录了流化床包衣设备风道积液与HEPA压差监测缺失等发现，可帮助读者对照清洁验证和设备设计审查的关注点。
2026年9月马耳他药监局对印度药企Glukem Biocare Private Limited进行了GMP检查，检查结束日期为2026年9月15日，相关的GMP不合规报告于2026年10月16日公布在EudraGMDP数据库。
The inspection resulted in a critical deficiency related to contamination risk in the Fluid Bed Coating (FBC) equipment due to an observed pool of liquid and residue in a section of the inlet air plenum of a fully cleaned FBC. The flaws were due to common design between FBCs (inclination of plenum not allowing gravity draining) and inadequate cleaning procedure. In addition, there was no detectability of a failure in HEPA filter integrity through real-time monitoring of pressure differential before and after the supply air HEPA filter of the Air Handling Units of the FBCs.
检查发现，由于在已彻底清洁的流化床包衣（FBC）设备进气风道某段观察到液体积聚和残留物，导致该设备存在与污染风险相关的关键缺陷。这些缺陷源于FBC设备共有的设计问题（风道倾斜角度不利于重力排液）以及清洗程序不足。此外，在FBC空气处理单元送风HEPA过滤器前后通过实时监测压差，无法检测出HEPA过滤器完整性失效。
There were eleven (11) major findings relating to:
本次检查共发现11项主要缺陷，包括：
Inadequate Master Batch Record instructions and production documentation
主批记录指引及生产文件不充分
Deficient process validation, including insufficient coverage of process, demonstration of its reproducibility and pellet homogeneity
工艺验证不足，涵盖工艺覆盖范围不够、可重复性未证实以及颗粒均匀性未验证
Incomplete cleaning validation
清洁验证未完成
Differential pressure excursions
压差异常波动
Deficient warehouse, sampling and dispensing controls
仓库管理、取样和分装控制不完善
Inadequate vendor qualification
供应商资质审核不足
Inadequate identification testing of incoming starting materials
原辅料来料鉴别测试不充分
Excipient risk assessments
辅料风险评估缺失
Out-of-Specification handling
OOS处理不当
Equipment qualification
设备确认不到位
Pest control.
虫害控制措施不足
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来源：GMP干货 · mp.weixin.qq.com