Home

Cgmp

Building a Culture of Quality and Compliance: Are 483's Just Part of Doing Business?


Pop quiz!  Where did the following snippets from FDA citations come from? (Winner gets a free coffee mug, runner up gets two -:))

  • Contamination during the manufacture of serum injectables?
  • Failure to measure or account for endotoxins?  
  • Failure to respond to adverse patient reactions?  
  • Presence of vermin and unsanitary conditions at the facility?

From 'On Pharma'

Criticizing the Cynicism Behind the Current Compounding Scandal


We wanted to criticize, in as forceful and graphic a way as possible, the cynical attitude of the compounding facility management, to call attention to the disgraceful conditions that were found at many of the compounding facilities that were inspected, and also to draw some attention to the political situation (e.g.

From 'On Pharma'