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发表于 2016-3-30 12:06:12
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Nature of non-compliance : Overall, 17 deficiencies were observed during the inspection, including 2 Critical and 4 Major deficiencies: [Critical 1] Manipulation and falsification of GMP documents (rewriting of records with change of content, an inconsistency of signatures and date in many records, etc.) were observed in different department; [Critical 2] Lack of data integrity in the QC laboratory (No access control, inadequate traceability and archiving practices, no audit trail, no restriction on the deleting of data, etc.) and falsification of the analytical results for residual solvents; [Major 1] Risk of contamination in grade B area; [Major 2] The change control related to (i)- the change of the identification number of some manufacturing equipment and (ii)- the merger project ofwas found deficient; [Major 3] Lack of documentation management, control, and retention of superseded or obsolete version; [Major 4] The company personnel was not adequately trained in GMPs as evidenced by the critical and major deficiencies identified during this inspection.
共发现了17条缺陷，其中两个严重缺陷，4个主要缺陷。严重缺陷1：不同部门的GMP文件造假（更换内容，重抄记录，多处记录的日期和签名不一致等）；严重缺陷2：QC实验室数据完整性不足（没有权限控制，没有审计追踪，没有删除数据的限制等），而且残留溶剂的分析结果造假；主要缺陷1：B级区有污染的风险；主要缺陷2：变更控制关于（i）一些设备的编码的变化和（ii） NCPC semisynthec和 Hebei Huari 的合并项目的变更不足；主要缺陷3：文件的管理、控制和撤销的文件的保留缺乏管理；主要缺陷4：这次检查过程中发现的严重和主要缺陷看来，公司的人员培训不到位。
CEP 2004-001 (Benzylpennicillin Procaine普鲁卡因, Sterile无菌) and CEP 2004-017 (Benzylpennicillin Procaine +1%lecithin 1%卵磷脂(无菌Sterile)被暂停.
欧盟GMP证书被收回。
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