www.fdanews.com/articles/175866-mhra-slaps-marksans-for-gmp-violations
MHRA Slaps Marksans for GMP Violations
March 23, 2016
Another drugmaker has been added to India’s laundry list of GMP violators.
The UK’s Medicines & Healthcare products Regulatory Agency has issued Marksans Pharma a restricted GMP certificate following a Nov. 23 to 25, 2015 inspection of its Goa plant that revealed quality systems deficiencies.
Inspectors had paid the plant a visit last March and found a number of serious major deficiencies involving data integrity, CAPA management, change controls, product quality reviews and internal audits.