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11月26日，欧盟EudraGMDP发布了齐鲁天和惠世制药有限公司的不符合报告，根据该报告，检查共发现约30个缺陷。其中，在质量管理，环境监测，交叉污染控制和清洁等领域发现了若干关键和主要缺陷。检查认为该公司的生产区域，设备，清洁工艺，维护，储存，公用系统和质量监管不适于在GMP条件下生产产品。如下：
公司名称：齐鲁天和惠世制药有限公司 地址：山东省济南市历城区董家镇849号 检查日期：2018-08-09 不符合报告签发日期：2018-11-26
Nature of non-compliance : 不符合情况：
In total, approximately 30 deficiencieswere observed. Amongst them, several critical and major deficiencies wereidentified in the field of Quality Management, Environmental Monitoring, CrossContamination Control and Cleaning. Production areas, Equipment, Cleaningprocesses, maintenance, storage, utilities and quality oversight are notsuitable to manufacture products under GMP-conditions. 共发现约30个缺陷。其中，在质量管理，环境监测，交叉污染控制和清洁等领域发现了若干关键和主要缺陷。生产区域，设备，清洁工艺，维护，储存，公用系统和质量监管不适于在GMP条件下生产产品。
The established cleaning procedure in thefacility's weighing room (3-16) of workshop #5 is not suitable for the handlingof highly potent substances to avoid cross-contamination. Triphosgene (a highlytoxic raw material for production of Piperacillin) is stored there. 在工厂第5车间的称量间（3-16）中建立的清洁程序不适合处理高活性物质以避免交叉污染。三光气（一种用于生产哌拉西林的剧毒原料）储存在该称量间。
In general, aseptic production processes donot comply with current EU-GMP regulations, e.g.: 总的而言，无菌生产工艺也不符合现行的EU-GMP规定，例如：
a) Environmental monitoring concept: I. Monitoring positions do not reflect worstcase locations based on risk evaluation, e.g. movement of operators (locationsof particle sensors and settle plates placed in corners, not covering operatorsmovement) II. Environmentalmonitoring starts after clean-up phase III. The inspectors have determined thatpermanently installed active air sampling devices are present within the RABSsystem (cleanroom class A); this equipment is not in use during routineproduction a）环境监测方面：I、监测位置不能反映基于风险评估的最坏情况位置，例如：操作员的活动（粒子传感器和沉降菌碟子放在角落，不覆盖操作员的活动）II。环境监测是在清洁完成后进行的。III.检查员已确定RABS系统（洁净室A级）内有安装固定式的主动空气采样装置;但该装置在常规生产中不使用。
b) Environmentalmonitoring procedure during production: I. Particlemonitoring cleanroom class A is not performed continuously during the wholeproduction process (to cover all operations) II. The tube length of mobile particle counters does not comply withcurrent state of the art requirements (ISO 14644-1, -2) III. In cleanroom class A, permanently installedparticle sensors are not appropriate for the particle size considered; e.g. thetube (bottle inlet after sterilization tunnel), shows multiple 90° bends and a lengthexceeding the state of the art requirements to avoid particle losses in thetubing. b）生产过程中的环境监测程序：I、在整个生产过程中洁净室A级的粒子监测不是不连续进行的（以覆盖所有操作）II。便携式颗粒计数器的管长度不符合现有技术要求（ISO 14644-1，-2）III。在A级洁净室中，永久安装的颗粒传感器不适于所考虑的颗粒大小;例如该管（灭菌隧道后的进瓶区域）显示有多个90°的弯并且长度超过现有技术要求，无法避免管中颗粒的损失。
c) Interventionsperformed by operators: (observed in Workshop #9) I. Removal of discarded bottles II. Emptyingthe discard box III. Forwarding ofstuck bottles on the conveyor belt c）操作员干扰：(在第9车间中发现）I、废弃瓶子的剔除II。清空丢弃物箱III。在传送带上处理卡瓶
d) Hygienicbehavior of operators: (observed in Workshop #9) I. no exchange procedure of gloves during production II.distribution of solid material (powder) all over clean room class B areathrough operators boots by walking back and forth. d）操作员的卫生行为:(在第9车间发现）I。在生产过程中没有手套更换程序II。固体材料（粉末）被操作员鞋子来回走动带到整个B级洁净室区域
e) Maintenanceof equipment: (observed in Workshop #9) I. Screw(conveyor belt) dropped down on the floor during operation (this was notrecognized by the operators, no actions were taken) e）设备维护:(在第9车间发现）I。操作期间螺丝钉（传送带）落在地板上（操作人员没有意识到，没有采取任何行动）
Last but not least: Cleaning concept andprocedures do not comply with EU-GMP regulations in the following: 最后但同样重要的是：清洁方法和程序不符合以下EU-GMP规定：
a) Cleaning concept of workshop #9 (asepticfilling line 2, FDF) lacks in a logical sequence of operation steps (e.g.starting of cleaning activities in cleanroom class A prior to removal ofremaining filled bottles of product still present at the conveyor belt; removalof discard box filled with un-stoppered bottles containing powder afterstarting of cleaning RABS (cleanroom class A) a）第9车间的清洁方法（无菌灌装线2，FDF））缺乏合理的操作步骤顺序（例如，在排空传送带上的已分装的产品之前，就开始A级洁净室的清洁活动；在开始清洁RABS（A级洁净室）后才去清除装有未加塞的粉末瓶的废弃箱
b) General procedures such as re-using cloths in clean roomclass A b）一般程序，例如A级洁净室中的衣服重复使用
c) Surface cleaning ofcleanroom class B is not effectively performed (no exchanging of mop-heads in aregular interval) c）无法有效地进行B级洁净室的表面清洁（未定期更换拖把头）
d) Mix-up ofcleaning activities in cleanroom class A and B d ）洁净室A级区和B级区的清洁活动存在交叉
e) Operators are not effectively trained on how to perform cleaningactivities (lack of detailed cleaning instructions in respective SOPs) Listingstopped due to 4000 char. restriction. e）操作员未能接受如何进行清洁活动的有效培训（相应SOP中缺少详细的清洁说明）由于字数限制未全部列出。限制。
Details available on request. Consideringthe CAPA-Plan provided by the company one critical deficiency was solved, theothers were reclassified to "major". Due to the severeness of thedeficiencies an on-site re-inspection is deemed necessary. 可根据要求提供详情。因公司提供了CAPA计划，一个关键缺陷已得到解决，其他的被重新归类为“主要”。由于缺陷严重，需要重新进行现场检查。
本文摘自 GMP办公室
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发表于 2018-12-2 21:31:02
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