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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