Based on these typical reactions to death—never to question the efficacy of the drug itself, and even less to probe whether manufacturing failures are to blame—there is a paucity of literature citing every instance where GMP non-compliance is linked to patient death or injury. Following are some examples, and I must stress some, of the most egregious examples of failure to follow GMP and the impact of that failure. Few though they may be, it is important to review these GMP failures from the past 30 years. Further information on all the following examples can be found in the public domain...
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