"Clear and precise" SOPs should be part of corporate compliance audit programs -- FDAer.
This article was originally published in The Tan Sheet
Executive Summary
CORPORATE COMPLIANCE AUDIT PROGRAMS SHOULD HAVE "CLEAR AND PRECISE" SOPs for all manufacturing procedures and practices, including all possible "don'ts," FDA Office of Enforcement Deputy Director Arvin Shroff, PhD, told a Food & Drug Law Institute meeting July 11. The recommendations were included in Shroff's unofficial list of "points to consider" for auditing programs. Many standard operating procedures (SOPs) "are written so broadly just to appease FDA...that you can almost drive a truck through it," Shroff remarked. "When you write a very broad SOP, you can run into problems yourselves -- your own employees can misuse them," he warned.