Report No : IT/NCR/API/3/2018

报告编号:IT/NCR/API/3/2018

The manufacturer : Yibin Lihao Bio-technology Co. Ltd.

企业名称:宜宾市利豪生物科技有限公司

Site address :Qihang Xi Road, Luolong Industrial Park, Yibin, Sichuan, 644104, China

地址:四川省宜宾罗龙工业集中区启航西路

Inspection results:Not comply with the Good Manufacturing Practice

检查结论:不符合GMP

Inspected by: Italian Medicines Agency

检查机构:意大利药监局

Inspected date:2018-10-31

检查日期:2018-10-31

Nature of non-compliance : 

违规情况:

The inspection identified 24 GMP deficiencies, of which 7 were categorised as major. The major deficiencies were found in the following areas: 1. Risk of contamination; 2. Buildings and facilities; 3. Equipment; 4. Storage of starting material; 5. Process; 6. Materials management, traceability of starting material; 7. Recovery of solvents.

检查共发现24条GMP缺陷,其中7条为主要缺陷。主要缺陷包括:1、污染风险;2、厂房和设施;3、设备;4、起始物料储存;5、工艺;6、物料管理,起始物料的可追溯性;7、溶剂回收。

Action taken/proposed by the NCA :

NCA采取/建议措施:

Requested Variation of the marketing authorisation(s) : Variations to existing MAs to remove the site are recommended

上市许可变更要求:变更已有上市许可以移除该工厂

Recall of batches already released: No recalls are recommended

召回已放行的批次: 未建议召回

Prohibition of supply: Prohibition of supply of crude heparin sodium manufactured by the site is recommended

禁止供应:禁止供应该工厂生产的肝素钠粗品

Suspension or voiding of CEP (action to be taken by EDQM) : Variation of involved CEPs is recommended

暂停或取消CEP(EDQM将采取的行动) :建议变更相关CEP。

公众号

GMP办公室

• 专业的GMP合规性研究组织

• 国内外(FDA、EMA、MHRA、CFDA、WHO、PIC/S等)GMP法规解读;

• 国内外制药行业GMP监管动态;

• GMP技术指南(ISPE、PDA、ISO、ASTM等)分享

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