印度工厂EU GMP不符合报告

公司名称：MARKSANS PHARMA LIMITED
检查地址：PLOT NO L-82, VERNA INDUSTRIAL ESTATE, VERNA, GOA,IN-403722, INDIA
检查时间：2015-11-25
产品：人用药，硬胶囊，软胶囊，片剂，品种巨多，自己看附件清单
检查方：英国药监

Nature of non-compliance : A prior inspection in March 2015 identified several serious Major deficiencies in the operation of the Pharmaceutical Quality System. These included systems to ensure Data integrity, Deviations and CAPA management, Change Controls, PQRs and Self-Inspection. A November 2015 re-inspection was carried out to assess the remediation plan from the company. There was a lack of evidence to demonstrate the effectiveness of resultant CAPAs taken and a lack of interim assurances to ensure that the on-going operations remain in compliance with GMP, including failures to carry out effective investigations. The November inspection identified a critical deficiency relating to systems to ensure Data Integrity in the following respects:

o Evidence of destruction of multiple parts of records of prime data

o Overall Data Integrity management and oversight

o Investigations into Missing and deleted data within the laboratory incomplete

o Procedures controlling Data Integrity within the laboratory not in place

不符合情况：在2015年3月检查中发现QMS几个严重的主要缺陷。包括确保数据完整性、偏差和CAPA管理、变更控制、PQR和自检的系统。2015年11月重新检查评估该公司的纠正计划。检查发现缺乏证据证明所采取的CAPA的有效性，缺乏临时保证来确保正在运行的操作保持符合GMP，包括未能进行有效的调查。11月的检查发现与确保数据完整性系统相关的关键缺陷，包括以下几方面：

1.    销毁多个原始数据的记录的证据

2.    整体数据完整性管理和监管

3.    对化验室数据丢失和删除的调查不完整

4.    化验室没有控制数据完整性程序



Action taken/proposed by the NCA : 采取/建议措施

Withdrawal, of current valid GMP certificate No. UK GMP 19826 Insp GMP 19826/39398-0003
Withdrawal of previous GMP Certificate No: UK GMP 19826 Insp GMP 19826/39398-0003

吊销现有GMP证书

Requested Variation of the marketing authorisation(s)
No further MA should be approved naming the site as manufacturer. Current pending MA applications should be held or refusal to grant stated whilst this statement of non-compliance remains in force.

要求上市许可进行变更，所有将该生产商列为生产场所的MA均不再批准。不符合通告有效期间，现在审批中的MA申报中止或拒绝颁发。

Recall of batches already released
There is no evidence of defective product currently on the market. Recall of products is not considered necessary.

没有证据证明目前有缺陷产品目前在市场上销售。可以不必考虑召回产品。

Prohibition of supply
No further batches of medicinal products considered non-critical to public health to be supplied to the market whilst this statement on non-compliance remains in force

禁止销售，此不符合通告有效期内，所有非关键药品均不得在欧盟市场上销售。
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