The Deviation Management SOP is applicable to all of the following EXCEPT: (Select ONE)
GMP/GDP deviations to any process, system or procedure or related to
clinical or commercial manufacturing, storage, testing, packaging, labeling,
laboratory, stability, and warehouse/distribution
Deviations associated with non GxP activities
GCP study or protocol deviations that are determined to have impact on
patient safety or data quality (potential serious breach); high probability of
reoccurrence or suspected Fraud
All BMS site and above site/function employees and contractors performing
or supporting GxP related activities excluding GLP
GVP deviations to any procedure, process, or to the global or local
pharmacovigilance system
Ok

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