金币
UID159590
帖子
主题
积分127
注册时间2014-2-14
最后登录1970-1-1
听众
性别保密
|
发表于 2015-3-3 15:48:56
|
显示全部楼层
本帖最后由 melancholy 于 2015-3-3 16:20 编辑
Is a certificate of suitability equivalent to a GMP certificate?
A certificate of suitability (CEP) is intended to demonstrate that the quality of a given substance can be suitably controlled by the relevant Ph. Eur. monograph(s), with additional tests if necessary (stated on the CEP), and is based on the assessment of a paper dossier submitted by the applicant.
As a complementary part to dossier evaluation, the CEP procedure foresees the performance of GMP inspections of sites involved in the manufacture of the respective substance. In line with EU legislation, the selection of sites to be inspected is based on a risk evaluation, which means that there is no routine inspection of all sites. As a consequence, a CEP may be granted with or without an inspection of the manufacturing site being performed.
A GMP certificate is granted by EU/EEA National Competent Authorities after an inspection (with or without the participation of the EDQM). The EDQM itself does not issue a GMP certificate after an inspection, but issues an attestation of inspection.
As an integral part of the CEP application, the manufacturer has to confirm that the substance in question is produced according to GMP requirements. However, the evaluation of the paper dossier does not evaluate GMP compliance. A certificate of suitability therefore cannot indicate GMP compliance, it is neither equivalent to a GMP certificate nor does it replace it.
A GMP certificate is a certificate issued following a GMP inspection, by the competent authority responsible for carrying out the inspection, to confirm the GMP compliance status of the inspected site.
GMP certificates are site-specific, but can be restricted to particular activities depending on the scope of the inspection (e.g., manufacturing activities related to a specific product). Directives 2001/82/EC and 2001/83/EC, as amended state that after every GMP inspection, and within 90 days of the inspection, a GMP certificate shall be issued to a manufacturer, if the outcome of the inspection shows that the manufacturer complies with GMP.
CEPs are certificates issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) to confirm that a certain active substance is produced according to the requirements of the relevant monograph of the European Pharmacopoeia or of the monograph on transmission spongiform encephalopathies.
CEPs can be used by companies when submitting an application for marketing authorisation, and replace much of the documentation required for the active substance in the marketing-authorisation dossier. GMP inspections of active-substance manufacturers can be requested by EDQM in the context of the CEP certification scheme.
EMA does not perform inspections. They are carried out on its behalf by the national competent authorities of the member states of the EEA, in connection with products under the centralised marketing-authorisation procedure.EMA does not issue GMP certificate. The competent authority responsible for carrying out the inspection issues the GMP certificate, or makes an entry of non-compliance into the EudraGMP database.
|
|
[复制链接]
|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
楼主