Data sheet
Id Counterfeit Pharmaceuticals with Portable Raman
Rigaku
The EDQM has suspended five CEPs in a little over a month, bringing the total to nine so far this year.
The suspended certificates of suitability (CEP) are Isosorbide mononitrate made by JP Laboratories , Biochem corporation’s Protamine sulfate and Huashu Pharmaceutical Corporatio’s Oxytetracycline dehydrate and Oxytetracycline hydrochlorides .
The European Directorate for the Quality of Medicines and Healthcare (EDQM) suspends CEPs if manufacturers fail to comply with its inspection requirements or do not operate in accordance with good manufacturing practices (GMP).
The latest suspensions are detailed in the organisation’s October monthly report , which also revealed that it conducted 18 manufacturing facility inspections this year – 14 of which were in Asia.
