A ''Top-Down Inspection'' is the FDA's latest inspection strategy in which inspectors are taught to evaluate the quality system and sampling quality system records.

The "top-down" approach begins each subsystem review with an evaluation of whether the firm has addressed the basic requirements in that subsystem by defining and documenting appropriate procedures. This is followed by an analysis of whether the firm has implemented the requirements of that subsystem.
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fda_public
created
Sun, 24 Jun 2012 15:07:28 GMT
creator
dirkjan
modified
Sun, 24 Jun 2012 15:07:28 GMT
modifier
dirkjan
tags
FDA
Term
creator
dirkjan