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2015-02-25 11:49:25| 分类： EDQM CEP|
EDQM
Certification of Substances Division PA/PH/CEP(15)06
Certification of suitability to the Monographs of the European Pharmacopoeia
Strasbourg, February 2015
CERTIFICATION MONTHLY REPORT
JANUARY 2015
2015年1月月报
New granted CEPs新颁发的CEP
| CEPs granted (total 2015) |
TSE | 3 |
Herbal | 0 |
Revised CEPs granted 修订后颁发的CEP
| CEPs granted (total 2015) |
TSE | 3 |
Herbal | 1 |
Time for treatment (rate of dossiers treated in time for chemical applications)
处理时间（化学CEP申报的文件处理速度）
Inspections 现场检查
| Month (current) 当前月 | Cumulated /year 本年累计 |
Nr of inspections审计次数 | 1 | 1 |
Asia 亚洲 | 1 | 1 |
EEA | 0 | 0 |
Other places 其它地区 | 0 | 0 |
Suspended /withdrawn CEPs 证书搁置和撤销
| Month (current) 当前月 |
Nr of CEPs supended 搁置CEP证书数量 | 1 |
Nr of CEPs expired 过效期CEP证书数量 | 4 |
Nr of CEPs withdrawn by EDQM 由EDQM撤销的证书数量 | 0 |
Nr of CEP withdrawn by holder 由持有人撤销的证书数量 | 1 |
Nr of closed applications 关闭的申报数量 | 8 |
Information published on the EDQM Website (www.edqm.eu)
? CEP Withdrawals: Due to a failure to fulfill the requirements of the CEP procedure with regards to updating the application and complying with GMP
n 18/12/14 Cholesterol CEP 2003-043
? CEP撤销：由于不满足CEP程序要求对申报进行更新且符合GMP
n 2014年12月18日，胆固醇 CEP 2003-043（该CEP由MILLIPORE US 60901 Kankakee 持有）
? ? CEP Suspensions: As a result of an inspection of the manufacturing site(s)
n 15/01/15 Colistin sulfate CEP 2004-258
? CEP搁置：对生产场所检查的结果
n 2015年1月15日，硫酸粘杆菌素，CEP2004-258（该CEP由ZHEJIANG APELOA KANGYU BIO-PHARMACEUTICAL CO., LTD. CN 322 109 Geshan持有，该公司不符合性报告参见欧洲GMP数据库）
来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201511715447179/
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