Writing Effective SOPs
Authored by Lora LaBrash and Steve Wilson
A quick review of 21 CFR parts 210, 211, and 820 will find numerous references to written procedures. These written procedures have come to be referred to as Standard Operating Procedures, (or SOPs, as they're more commonly known), and are a tool used in most every industry to help achieve uniform results. Creating a written procedure that everyone can follow takes the guesswork and uncertainty out of the process equation. Our experience has shown that a written procedure will contain certain elements.
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