The UK’s regulatory authority Medicines and Healthcare products Regulatory Agency (MHRA)recently published an inspection report that identified a GlaxoSmithKline (GSK) production facility in Tianjin, China was non compliant with Good Manufacturing Practices (GMPs).
The site produces the heartburn treatment Zantac which marketed in various countries which includes the UK, Germany, Ireland, Portugal, Austria, Denmark, Greece, Finland, Netherlands, Norway, Belgium, France and Italy.
MHRA inspected the manufacturing site in June and on recently released this report of non-compliance stating the facility “should not be named on any marketing authorizations whilst this statement remains in place,” with respect to the EU’s EudraGMDP website.
The cautions follow other problems GSK has had in China, which includes a bribery scandal from a year ago for which the organization was penalized almost $500M.
The inspectors recognized sterility problems, in addition to primary and secondary packaging insufficiencies, along with issues with quality control examining.
“A crucial insufficiency was cited with regards to system failures to make sure that the manufacture of medicinal products were fit for their intended use, complied with the specifications of the Marketing Authorisation and did not place sufferers at risk due to insufficient safety, quality or efficacy,” the regulatory authority said.
Since 2005, GSK recognized tablet discoloration in the stability samples while in trials which did not fulfill the shelf life specification.
“No steps were taken to evaluate the risk of the remaining products in the markets,” MHRA says. “Adverse trends in stability indicating attributes were noticed but not examined.”
Additionally, product impact evaluations unsuccessful to make sure that the defective product was not possibly supplied to the user, and the organization also unsuccessful to notify regulators of the discovery of these “faulty goods.”
GSK was also cited for failing to address the real cause of the problems because of inadequate Corrective and Preventive Actions (CAPA) that weren’t properly applied. The organization also unsuccessful to perform effective investigations in a timely manner.
A series of explosions in August, which wiped out over 100 people in Tianjin, also had an effect on this same GSK manufacturing site, with respect to media reports. Reacting to these issues GSK said looking into the situation.