Inspection in June uncovered a 'critical deficiency' related to stability problems
A GlaxoSmithKline plant in Tianjin in China, which was hit by a series of explosions in August, has had its Good Manufacturing Practice (GMP) certificate withdrawn by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The UK regulator has issued a notice of non-compliance for GSK's plant in China after an inspection in June uncovered a 'critical deficiency' related to stability problems with some non-sterile products made at the plant.
The GSK (Tianjin) Co Ltd facility has not been operational since the explosions in the Tianjin industrial district, but the problems cited by the MHRA date back to 2005.
The MHRA said since that time GSK had identified tablet discoloration in samples taken during stability trials, which 'did not meet the shelf life specification'.
However, the MHRA said no action was taken by GSK to assess the risk of the remaining products in the markets and it also failed 'to notify competent authorities on the discovery of defective products', nor did it 'address the root cause due to ineffective corrective and preventive actions (CAPA)' or 'conduct effective investigations in a timely manner'.
The Tianjin site, according to the MHRA notice posted on the EudraGMP database, has been issued 'a statement of non compliance and should not be named on any marketing authorisations whilst this statement remains in place'.
GSK said the withdrawal of the certificate affects heartburn drug Zantac, which is the only product supplied to Europe from the Tianjin site.