Rx-360 News Flash
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EDQM (European Directorate for the Quality of Medicines) has suspended more certificates for various APIs because their manufacturers have failed or refused inspections.   The latest round brings the number of suspended or withdrawn certificates to date in 2010 to 25.  19 of these suspensions occurred during the second half of 2010.

All of the suppliers included in the list were from Asia, with the exception of Northern Ireland's Norbrook Laboratories (whose suspended CEP for oxytetracycline hydrochloride has since been reinstated).

Nine of the suspended or withdrawn CEPs are assigned to six Chinese companies in the list, with two Indian firms accounting for another six CEPs. Two CEPs were from a Korean supplier and another was from a Thai company.
 

CEP Suspensions 2H 2010

To read more check out the article at SecuringPharma by clicking here.
 

EDQM has created a process to certify pharmaceutical substances.   A couple of tricks that will help you use the EDQM database. 

1. If in the “Search a” field you select “Status of certificate” from the pull down menu, and type in  “valid” in the search field, then you can get a list of all suppliers and materials that have an EDQM certification.  
2. If in the “Search a” field you select “Status of certificate” from the pull down menu, and type in  “Withdrawn by EDQM” in the search filed, then you can get a list of all suppliers and materials where the certificates were withdrawn by EDQM for GMP deficiencies or insufficient information no longer in line with regulatory requirements.   

The actual inspection findings are not available for public view, which does decrease the usefulness of the information.  However, knowing with suppliers and materials have had their certification withdrawn by the EDQM is very useful and should raise red flags, that required additional investigation if this happens to one of your suppliers.

To access the database click here.