EU GMP 不合格报告：重庆赛维药业有限公司

检查机构：

法国国家药品保健品安全机构

生产商：重庆赛维药业有限公司

工厂地址：中国重庆金龙工业区铜梁县铜合大道531号

报告编号：17MPP048NCR

不符合情况：

一共发现22条缺陷，其中1条关键缺陷，3条主要缺陷。

关键缺陷：篡改、倒签和伪造GMP文件，例如批生产记录、起始物料生产商审计报告、气相和高效液相。

主要缺陷1：未申报的车间无法追踪所进行的活动

主要缺陷2：产品的储存未经确认而缺乏任何追溯

主要缺陷3：批生产记录的发放标准不佳

英文原文：

French National Agency for Medicines and Health Products Safety

The  manufacturer  :CHONGQING SUCCEWAY PHARMACEUTICAL CO LTD

Site address: 531 Tonghe Avenue, Tongliang County, Jinlong Industrial District, CHONGQING, SICHUAN, 402566, China

Report No :17MPP048NCR

Nature of non-compliance :

Overall around 22 deficiencies were observed, out of which one was classified as critical and three as major.

Critical: manipulation, backdating and falsification of GMP documents such as batch manufacturing record, report of starting material manufacturer audit, GC and HPLC chromatograms.

Major 1: undeclared workshop without any traceability of the activities undertaken.

Major 2: undeclared storage of unidentified product without any traceability.

Major 3: poor standards for issuance of batch manufacturing records.