Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
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BMT Review <strong>of</strong> a BLADrug Substance‣ Microbial control‣ Release <strong>of</strong> bulk drug substance‣ Qualification <strong>of</strong> in-process and releasemicrobial methods‣ Media and buffers‣ Column cleaning/sanitization/storage‣ Shipping validation18