How to write standard operating procedures: values and a practical guide

  • Kidanemariam G/Michael Beyene Ethiopian Food, Medicine and Healthcare Administration and Control Authority, Addis Ababa, Ethiopia
  • Solomon Nadew
  • Wassu Gedefaw Ali
  • Awot Gebregzabiher Gebrehiwot
  • Solomon Getachew Atsibeha

Abstract

Standard operating procedure (SOP) is detailed, written step-by-step instructions for achieving uniformity while performing specific tasks to minimize variations of repeated tasks and plays a key role in the implementation of a quality management system. It is a document that describes the procedures that will be followed to accomplish various tasks. The procedures are organic documents and best-written SOPs fail if they are not followed. Poorly written, unavailable, and inadequate SOPs hamper working processes and lead to non-compliance in the implementation of quality management systems. A well-crafted SOP offers clear direction and instruction that minimizes deviations at different times using different personnel. The SOPs should be user-friendly and describes the processes in the sequential manner in which they are intended to occur and thus leading to a logical flow of events. In this article, SOP writing is summarised in seven steps, namely (i) Preparing, (ii) Reviewing, (iii) Updating, (iv) Maintaining, (v) Distributing, (vi) Archiving, and (vii) Training.

Keywords: Standard Operating Procedures (SOP), Quality Management System (QMS), SOP Preparation, SOP Guidance

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How to Cite
Beyene, K. G., S. Nadew, W. G. Ali, A. G. Gebrehiwot, and S. G. Atsibeha. “How to Write Standard Operating Procedures: Values and a Practical Guide”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 32-37, doi:10.22270/ijdra.v10i4.557.

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