Standard operating procedure

For the 2008 documentary film by this name, see Standard Operating Procedure (film).

The term standard operating procedure, or SOP, is used in a variety of different contexts, such as healthcare, aviation, education, industry or the military.

The U.S. military uses the term Standing — rather than Standard — Operating Procedure, because a military SOP refers to a unit's unique procedures, which are not standard to another unit. "Standard" would imply that the operating procedure is the only correct one across all units.

Clinical research and practice

In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs get usually applied in pharmaceutical processing and for related clinical studies. There the focus is set on always repeated applying of unchanged processes and procedures and its documenting, hence supporting the segregation of origins, causes and effects. Further aspplication is with triage, when limited resources get used according to an assessment on ranking, urgence and staffing possibilities.

Business and manufacturing practice

An SOP is a written document or instruction detailing all steps and activities of a process or procedure. ISO 9001 essentially requires the documentation of all procedures used in any manufacturing process that could affect the quality of the product.

See also

• Quality control
• GxP
• Rules of engagement
• Runbook
• Run Book Automation
• Operational research
• Bureaucracy

External links

• Clinical Trials Standard Operating Procedures Templates for Clinical Investigators
• ICH Guidance E6: Good Clinical Practice: Consolidated guideline
• European Medicines Agency Guideline for Good Clinical Practice
• SOP Writing for Clinical Trials: Staff Training Aspects by Akanksha Saxena, International Biopharmaceutical Association Publication, 2005.
• GMP SOP Templates for pharmaceutical operations