EDQM suspends five CEPs after inspecting Chinese Manufacturer Sites
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The EDQM announced on their webpage the suspension of 5 CEPs. All of the CEP owners are Chinese companies.
As a result of an inspection of the manufacturing sites the following CEPs were suspended:
| Date | Substance name | CEP Number |
| 14/04/09 | Benzylpenicillin, Procaine Sterile | CEP 2004-001 |
| 14/04/09 | Benzylpenicillin, Procaine Sterile, lecithin coated (1%) | CEP 2004-017 |
| 14/04/09 | Dihydrostreptomycin sulphate for veterinary use | CEP 2000-069 |
| 14/04/09 | Neomycin sulphate | CEP 2001-317 |
| 10/03/09 | Clindamycin phosphate | CEP 2003-060 |
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 certificates suspended for a defined period (for GMP deficiencies) are identified by status of SUSPENDED. In total 29 suspended CEPs are currently listed. Nearly all of the suspended CEP holders are Chinese manufacturers and some Indian manufactures.
More information about the procedure for a suspension can be found in our GMP News from April 22, 2009.
Source: EDQM Webpage: www.edqm.eu.
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