EDQM Announces the Suspension of Further CEPs
Register now for ECA's GMP Newsletter
As a result of an inspection at a manufacturing site in India and one in China, the EDQM announces the suspension of the following CEPs:
| Date | Substance name | CEP Number |
| 4/01/2010 | Zidovudine | CEP 2003-276 |
| 14/12/09 | Carbamazepine | CEP 2002-141 |
In addition the EDQM announces the withdrawal of two CEPs from Chinese manufacturers as a failure to fulfil, after a suspension, the requirements of the CEP procedure with regard to the updating of the application and compliance with GMP. The information is given below:
| Date | Substance name | CEP Number |
| 12/11/09 | Doxycycline hyclate | CEP 2003-225 |
| 12/11/09 | Doxycycline monohydrate | CEP 2003-226 |
In our previous GMP News we informed about further suspensions and about the EDQM Guideline that defines the criteria for suspensions and cancellations of CEPs.
The information is used by a number of EU authorities. Previous suspensions showed that some EU authorities took immediate measures after CEP suspensions.
The database of EDQM is accessible to the public. Industry and authority can search for the name and address of the CEP holders.
Source: EDQM webpage
Conference Recommendations
Related GMP News
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