20Introduction to Refine
It is not necessary to change. Survival is not mandatory.
Dr. W. Edwards Deming
20.1 INTRODUCTION
In the Pharmaceutical Industry (pharma), we are plagued with an enormous amount of regulatory oversight, more than in any other industry. The Food and Drug Administration (FDA) can walk into a facility at any time and do an inspection, and the production facility must give them all the support and resources that they request, in labor, information, or any other resource. This is in addition to regularly scheduled inspections. Any deviation from the regulatory requirements can cause an immediate shutdown of the entire facility. Therefore, when a pharma production facility develops a strategy plan, it is filled with quality ...
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