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 application is with triage, when limited resources get used according to an assessment on ranking, urgence and staffing possibilities. Study director is mainly responsible for SOP. Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP.
SOP's can also provide employees with a reference to common business practices, activities, or tasks. New employees use an SOP to answer questions without having to interrupt supervisors to ask how an operation is performed. The international quality standard ISO 9001 essentially requires the determination of processes (documented as standard operating procedures) used in any manufacturing process that could affect the quality of the product.
Read more about this topic: Standard Operating Procedure
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