GXP

GMP Failures: Ignorance or Arrogance? | IVT

GMP problems are not limited to the US pharmaceutical industry. During 1999-2010, serious GMP failings occurred at Chiron in the UK and Pan Pharmaceuticals in Australia, to say nothing of the legion of other companies in other countries with GMP problems that never hit the headlines. It would be easy to assume that because GMP regulations have been around for approximately 50 years, the pharmaceutical industry would know what is expected.  The situation that led to GSK losing a US$750-million lawsuit was multi-layered and involved personnel in all levels of the company.  In taking a...

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