Chinese API supplier under FDA scrutiny
Chinese active ingredient manufacturer Sichuan Pharmaceutical has been sent a warning by the US FDA for failing to sort out quality violations at one of its manufacturing facilities.
An inspection of the plant in Pengzhou, Sichuan, in June 2010 uncovered a number of deviations from Good Manufacturing Practice (GMP), including failure to have procedures in place to prevent cross-contamination occurring.
The letter notes that Sichuan made API in one workshop which was adjacent to another unit making both APIs and injectable products, but the company “failed to have adequate controls and monitoring program to prevent cross-contamination”.
Sichuan was also found to be making an API in a unit previously used to make another product without carrying out suitable decontamination and renovation of the plant. Testing of one product for contamination with another was not a sufficient safeguard, said the agency.
Sichuan has also failed to register all the APIs it distributes into the US market in violation of US law, said the FDA.
…while EDQM revokes API certificates
Meanwhile, the European Directorate on the Quality of Medicines and Healthcare (EDQM) has suspended one certificate of suitability (CEP) for an API and withdrawn three more after the companies making them failed to meet standards.
– Taihya Natural Plant Pharmaceutical of Shangzhou in China had its CEP for cancer drug paclitaxel withdrawn by the EDQM based on failure to meet standards during an inspection of the plant at which it was made.
– Italian ingredient manufacturer Erredue SpA has had CEPs withdrawn for antiviral ribavirin and tiamulin hydrogen (a veterinary agent) after failing to keep the dossiers on the ingredients up-to-date and in compliance with GMP.
– Bakul Aromatics and Chemicals of India has had its CEP for asthma drug theophylline suspended by the EDQM due to “a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP”.
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