Further CEPs suspended and withdrawn by EDQM
The EDQM continues to inspect manufacuturers of APIs - especially in Asia. As a consequence of these inspections a number of CEPs were supspended or withdrawn (GMP News 20.1.2010 and GMP News 29.04.2009). In addition to previous announcements the EDQM published the suspension of 3 and the withdrawal of 4 CEPs on their website. All of the CEP owners are Indian and Chinese companies.
The EDQM announces the suspension of the following CEPs as a result of an inspection of the manufacturing sites:
| Date | Substance name | CEP Number |
| 14/12/2009 | Carbamazepine | CEP 2002-141 |
| 31/03/2010 | Chlorpropamide | CEP 2000-020 |
| 31/03/2010 | Tolbutamide | CEP 2000-021 |
The EDQM announces the withdrawal of the following CEP as a result of an inspection of the manufacturing sites:
| Date | Substance name | CEP Number |
| 26/02/2010 | Propyphenazone | CEP 2001-041 |
| 26/02/2010 | Phenazone | CEP 2001-042 |
| 26/02/2010 | Metamizole sodium | CEP 2001-220 |
| 04/01/2010 | Zidovudine | CEP 2003-276 |
The EDQM offers a database in which the information on the Certificates of Suitability (CEPs) are available for public. The database offers a comprehensive search tool. It is possible to search for:
- Name of the certified substance or
- Holder of the certificate or
- Certificate number or
- Monograph number or
- Status of the certificate
The database can be found here.
Source: www.edqm.eu.
Conference Recommendations
Related GMP News
28/08/2018
22/08/2018
15/08/2018
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity