Simplifying Global Compliance
Bristol Myers Squibb - August 13, 2010
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch of any of its components to meet any of its specifications whether or not the batch has been already distributed.
Specifically, your firm does not always identify, document and/or investigate discrepancies or atypical events that may impact the potency, quality, identity or purity of a material or product.
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