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GMP non-Compliance causes further CEP Suspensions


EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP) following an inspection of the manufacturing site:

CEP 2001-341-Rev 02/Azathioprine
CEP 2003- 066-Rev 00/Ticlopidine HCl
CEP 2003-206-Rev 00/Haloperidol
CEP 2004-135-Rev 01/Risperidone
CEP 2005-084-Rev 00/Diphenoxylate HCl

The manufacturer concerned is: RPG Life Sciences Limited, 25, M.I.D.C Land, Thane Belapur Road, 400 705 Navi Mumbai, Maharashtra, India

In addition the EDQM suspended the CEP:

Nifuroxazide CEP 2006-074

The manufacturer concerned is: Suzhou No.5 Pharmaceutical Factory Co., Ltd. ,215 008 Suzhou, China

Due to a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP (e.g. refusal, of inspection, reconstruction/restoration of site(s), to achieve GMP level, and temporary closure) the following CEP has been suspended:

Troxerutin CEP 2006-153

The manufacturer concerned is: Ergypharm, 67452 Mundolsheim, France

If the EDQM withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period.

If any medicines on the market contain these active substances from the concerned active substance manufacturers, the marketing authorisation holder should report the product defect to the competent EU authority

Source: EDQM and Danish Medicines Agency