欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
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 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。
摘自GMP办公室
| 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2018-11-27 09:14:39
置顶卡
变色卡