Standard operating procedure
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The term standard operating procedure, or SOP, is used in a variety of different contexts, such as healthcare, 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.
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[edit] Clinical research
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".
[edit] 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.[1]
[edit] See also
- Quality control
- GxP
- Rules of engagement
- Runbook
- Run Book Automation
- Operational research
- Bureaucracy
[edit] References
[edit] 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
