GMP不符合报告：浙江海正药业
近日,欧盟EudraGMDP发布关于浙江海正药业台州工厂(2家)的GMP不符合报告,如下:
Nature of non-compliance :
不符合情况:
Overall 25 deficiencies were identified during the inspection, 2 critical and 5 major. The critical deficiencies detected were motivated by a deficient handling of non-cytotoxic, cytotoxic, hazardous and highly potent substances in multi-product facilities (i.e. mainly in buildings Y36, Y37, Y38, Y39 at Yantou Campus and E08 at East Factory Campus, but also other buildings could pose some risks, such as Y20, Y33, Y35, Y50 at Yantou Campus).
在检查期间发现了25个缺陷,2个严重缺陷和5个主要缺陷。检查发现的严重缺陷是由于在多产品设施中对非细胞毒性、细胞毒性、危险性和强毒性物质的处理不足(即主要是位于岩头厂区的Y36、Y37、Y38、Y39幢和东厂的E08号楼,还有其他建筑物也可能造成一些风险,如岩头厂区的Y20、Y33、Y35、Y50幢)。
Risk of cross contamination in these facilities had not been properly identified and mitigated.
这些设施中的交叉污染风险尚未得到适当识别和减轻。
The major deficiencies observed were identified in the cleaning validation, purified water monitoring, intermediate hold-time validation, recovering solvent process.
主要缺陷项主要涉及清洁验证、纯化水监测、中间产品保留时间验证、溶剂回收等方面。
2、不符合报告中建议采取的措施:
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不应授予此生产商原料药的任何新的/正在进行的销售许可或变更申请;
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建议提交一份变更申请来引入原料药的可替代生产商;
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由于2016年的非符合性申明,此厂区的活动已在欧盟市场暂停,且仅生产关键的原料药并进口至欧盟,因此目前不建议召回该厂区所生产的原料药,除非检测结果不符合质量标准;
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建议禁止供应上述原料药,除非没有替代供应商且存在短缺风险。
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其他评价:要求市场销售持有人联系相关国家主管当局,以核实所涉及原料药是否被认为是关键的。对于这些原料药,没有替代供应商,并且有原料短缺的风险,将不在不符合声明的范围之内。
海正药业发布公告:
