原料药企业在筹划或实施申请CEP证书时，最关心的一个问题往往是，欧盟会实施GMP现场检查吗？如果会实施检查，那何时检查呢？
确切地说，根据历史经验和检查实践，EDQM以往基本上是在颁发GMP证书后，基于产品的复杂程度和用途等风险因素，择机实施GMP检查。
而现在有了变化的迹象，近日我公司多个客户收到的“Site status review”或者“preliminary info”邮件，说明正在审评中CEP亦将列入现场检查计划，值得意向企业关注。
参见下表欧盟真实信息。
Name |
The Description |
Date |
note |
AAAA |
Your company is listed in one or more certificates of suitability to the monographs of the European Pharmacopoeia (CEP) either granted or currently under assessment by the EDQM. In the frame of the EDQM Inspection programme and in accordance with your statement of willingness to be inspected, we are pleased to inform you that an internal risk assessment process is now in place to evaluate the GMP status and activities of the following manufacturing site： |
2022.04 |
The red letter is begun to use in the letter |
ABAB |
Your company is listed in one or more certificates of suitability to the monographs of the European Pharmacopoeia (CEP) either granted or currently under assessment by the EDQM. In the frame of the EDQM Inspection programme and in accordance with your statement of willingness to be inspected, we are pleased to inform you that an internal risk assessment process is now in place to evaluate the GMP status and activities of the following manufacturing site |
2022.01 |
The red letter is begun to use in the notification |
AABB |
Your company AABB CO., LTD is listed in a certificate of suitability to the monographs of the European Pharmacopoeia (CEP) granted by the EDQM. In the frame of the EDQM Inspection programme and in accordance with your statement of willingness to be inspected, we are pleased to inform you that the status of the following manufacturing site will be evaluated. Besides, your site may be subject to an inspection within the EDQM programme at any time. |
2020.06 |
|
BBBB |
In accordance with your statement of willingness to be inspected, we are pleased to confirm to you that the below mentioned manufacturing site may be subject to an inspection within the EDQM programme for the inspection of starting materials manufacturers and brokers who have requested or are holders of a Certificate of Suitability to the European Pharmacopoeia monographs. In order to consider relevance and priority of an inspection, please fill in the enclosed form with requested information and return it within 3 working days (deadline is 15th of January 2020 end of the day) after the receipt of this e-mail. Note that failing to answer this mail may be likely to make us considering an inspection as a priority and/or take actions against your CEPs/CEP applications. |
2020.01 |
Cesp |
AACC |
In accordance with your statement of willingness to be inspected, we are pleased to confirm you that your manufacturing site: may be subject to an inspection within the EDQM program at any time. |
2019.04 |
|
CCCC |
In accordance with your statement of willingness to be inspected, we are pleased to confirm to you that the below mentioned manufacturing site may be subject to an inspection within the EDQM programme for the inspection of starting materials manufacturers and brokers who have requested or are holders of a Certificate of Suitability to the European Pharmacopoeia monographs. |
2018.11 |
|
AADD |
In accordance with your statement of willingness to be inspected, we are pleased to confirm to you that the below mentioned manufacturing site may be subject to an inspection within the EDQM programme for the inspection of starting materials manufacturers and brokers who have requested or are holders of a Certificate of Suitability to the European Pharmacopoeia monographs. In order to consider relevance and priority of an inspection, please fill in the enclosed form with requested information and return it within 1 week after the receipt of this e-mail. Note that failing to answer this mail may be likely to make us considering an inspection as a priority and/or take actions against your CEPs/CEP applications. |
2018.03 |