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Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) means documented procedures which describe how to perform tests or activities not specified in detail in study plans or test guidelines. Appropriate and technically valid SOPs should be established. SOPs are generally written by persons who are familiar with the process or instrument, and reviewed for technical content and conformation to quality and regulatory requirements. SOPs are intended to ensure the quality and integrity of the data generated.

Hence, SOPs should be written in such a manner that it is unambiguous, chronological and complete in itself. Technical content should have sufficient details so that someone with a basic understanding of the task can perform it after being trained on the SOP. It is customary to translate SOPs to vernacular language(s) to facilitate understanding and usage. Each SOP should be assigned a unique identification number and version number.  Finalized SOPs have to be approved by the management before they can be released for use. The original signed SOP, the Master Copy, is usually archived while controlled copies are distributed to the Users. Study Personnel should have access to current SOPs relevant to the activities being performed by them, at the site of activity.

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By | 2017-05-17T11:30:44+00:00 October 26th, 2014|Categories: Regulatory|Tags: |Comments Off on Standard Operating Procedures (SOPs)

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