Standard operating procedure: Difference between revisions
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The terms '''standard operating procedure''' or '''SOP''', is used in a variety of different contexts, such as healthcare, education, industry or the military. |
The terms '''standard operating procedure''' or '''SOP''', is used in a variety of different contexts, such as healthcare, education, industry or the military. |
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==Military use== |
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In [[military terminology]] SOP's describe a [[Procedure (term)|procedure]] or set of procedures to perform a given operation or [[Evolution (disambiguation)|evolution]] or in reaction to a given event. It has been misused repeatedly for so long that the accepted meaning of SOP is Standard Operating Procedure. However, the original and correct meaning to this abbreviation is Standing Operating Procedure. A Standard Procedure does not need explanation or publication because it is standard. However, a procedure that needs clarification for a limited time or limited use is a procedure that is standing for that for the time or use. |
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==Clinical research== |
==Clinical research== |
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Revision as of 09:30, 16 July 2011
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The terms standard operating procedure or SOP, is used in a variety of different contexts, such as healthcare, education, industry or the military.
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".
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]
See also
- Quality control
- GxP
- Rules of engagement
- Runbook
- Run Book Automation
- Operational research
- Bureaucracy
References
External links
- 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