Regulatory Focus™ > News Articles > Updated: UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance

Updated: UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance

Posted 23 October 2015 | By Zachary Brennan 

Updated: UK’s MHRA Calls Out GSK China Plant Over GMP Non-Compliance

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 was 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Simon Steel, spokesman for GSK, confirmed to RAPS that MHRA has withdrawn the GMP certificates from the site, which is currently not in operations as it undergoes repairs from an August explosion in Tianjin.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 saying the facility “should not be named on any marketing authorizations whilst this statement remains in place,” according to the EU’s EudraGMDP website.

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.

Specifics

The inspectors identified sterility issues, in addition to primary and secondary packaging deficiencies, as well as problems with quality control testing.

“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 Authorisation 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 markets,” MHRA says. “Adverse trends in stability-indicating attributes were observed but not investigated.”

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.

Explosion

A series of explosions on 12 August, which killed more than 100 people in Tianjin, also had an impact on this same GSK manufacturing facility, according to media reports.

EudraGMDP Filing


Categories: Regulatory News

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