Institute of Good Manufacturing Practices India
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released an inspection report that found a GlaxoSmithKline (GSK) manufacturing facility in Tianjin, China highlighting non-compliant with Good Manufacturing Practices (GMPs).
Simon Steel, spokesman for GSK, confirmed to RAPS that MHRA has withdrawn the GMP certificates from the site, which is currently not in operations as it undergoes repairs from an August explosion in Tianjin.
The site manufactures the heartburn treatment Zantac for markets including the UK, Austria, Belgium, Denmark, Finland, Germany, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal and others.
MHRA inspected the site in June and on Friday issued this statement of non-compliance. The warnings follow other issues GSK has had in China, including a bribery scandal from a year ago for which the company was fined nearly $500M.The inspectors identified quality control testing, primary and secondary deficiencies as well as sterility testing issues.
“A critical deficiency was cited with regards to system failures to ensure that the manufacture of medicinal products were fit for their intended use, complied with the requirements of the Marketing Authorization and did not place patients at risk due to inadequate safety, quality or efficacy,” the MHRA said. Since 2005, GSK identified tablet discoloration in the stability samples during trials which did not meet the shelf life specification.
“No action was taken to assess the risk of the remaining products in the market and adverse trends in stability-indicating attributes were observed but not investigated” said MHRA.
In addition, product impact assessments failed to ensure that the defective product was not potentially supplied to the user, and the company also failed to notify regulators of the discovery of these “defective products.” GSK was also cited for failing to address the root cause of the issues because of ineffective Corrective and Preventive Actions (CAPA) that weren’t appropriately implemented. The company also failed to conduct effective investigations in a timely manner.