Possible API Contamination at Chinese CMO Leads to Canadian Recalls
An inspection by the European Directorate for the Quality of Medicines and Healthcare (EDQM) at the Suzhou No. 4 Pharmaceutical Factory, China has given rise to concerns that the antibiotic product Clindamycin may have contaminated the anti-psychotic product Quetiapine during the manufacturing process.
The Chinese company manufactures the active pharmaceutical ingredient (API) on behalf of Canadian firms Cobalt Pharmaceuticals Company, Laboratoires Riva and Sanis Health and, in consultation with Health Canada, all three companies have issued voluntary recalls.
Though no adverse effects have been reported relating to the use of Quetiapine in Canada, Patricia Petrisor a spokesperson for Cobalt – who also supplies Riva with the finished formulation – told Outsourcing-Pharma.com that the company “is working with Health Canada officials to outline and implement a coordinated voluntary recall” to ensure full safety of the product.
“In addition, Cobalt has distributed a letter to all customers informing them of the voluntary recall, and providing steps to collect and return all Cobalt Quetiapine products to the manufacturer,” she added.
The EDQM noted that Suzhou No. 4‘s cleaning records for a piece of common equipment were found to be inadequate and could not rule out the presence of clindamycin hydrochloride in the API. This poses the risk of a serious allergic reaction for users of the drug.
Petrisor was not, however, able to give a “timeline for manufacturing, distribution or re-stocking” Quetiapine products for now.
Health Canada spokesperson Blossom Leung also confirmed to us that Riva and Sanis had issued recalls and were advising health care professionals to contact any patients who may be affected whilst “alternative authorised and not affected Quetiapine products” were sourced for the Canadian market.
Leung added the regulatory body “will monitor the recall and will inform Canadians if new information arises.”
Overseas GMP
Regulating manufacturing practices for overseas CMOs (contract manufacturing organisations) is a necessity that has led Health Canada to recently amend its GMP requirements for all APIs to adhere to internationally accepted standards.
According to Leung: “The new amendments create a new record-keeping requirement that will help us trace active ingredients through the system, from their place of origin to the manufacturers that put them into products for consumers.”
