How to write standard operating procedures: values and a practical guide
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.
2. Hamrell Michael R, Wagman B. Standard operating procedures in clinical research: a beginner's guide. The Quality Assurance Journal: The Quality Assurance Journal for Pharmaceutical, Health and Environmental Professionals. 2001;5(2):93-7.
3. ICH Harmonised Guideline: Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2). European Medicines Agency London, UK; 2016. [Internet]. US FDA; 2016 Apr 12 [cited 2022 Aug 21]. Available from:
4. US EPA. Guidance for preparing Standard Operating Procedures.: Office of Environmental Information; 2007.
5. Hattemer‐Apostel R. Standard operating procedures‐a novel perspective. The Quality Assurance Journal: The Quality Assurance Journal for Pharmaceutical, Health and Environmental Professionals. 2001;5(4):207-19.
6. De Treville S, Antonakis J, Edelson NM. Can standard operating procedures be motivating? Reconciling process variability issues and behavioural outcomes. Total quality management and business excellence. 2005;16(2):231-41.
7. Akyar I. Standard operating procedures (what are they good for?). Latest research into quality control. 2012:367-91.
8. Bohaychuk W, Ball G. Standard operating procedures for clinical research personnel—part 1. The Quality Assurance Journal: The Quality Assurance Journal for Pharmaceutical, Health and Environmental Professionals. 1998;3(3):137-50.
9. Gough J, Hamrell M. Standard operating procedures (SOPs): How to write them to be effective tools. Drug Information Journal. 2010;44(4):463-8.
10. Gough J, Hamrell M. Standard operating procedures (SOPs): Why companies must have them, and why they need them. Drug Information Journal. 2009;43(1):69-74.
11. Isaman V, Thelin R. Standard operating procedures (SOPs): reason for, types of, adequacy, approval, and deviations from and revisions to. Quality assurance (San Diego, Calif). 1995;4(3):167-71.
12. Clive Celine M. Handbook of SOPs for good clinical practice: CRC Press; 2004.
13. Sanjay KJ, Bhatwadekar N. Standard operating procedures (SOP)-Back Bone of Pharmaceutical Industries. Pharmaaceutical reviews; 2008.
14. A Basic Guide to Writing Effective Standard Operating Procedures (SOPs) [Internet]. FDA Groups; 2022 [cited 2022 September 18]. Available from:
15. Frank D. How to write SOPs that help increase consistency and improve performance quality in Standard Operating Procedures: A Writing Guide. Cleaning & Maintainance Management; 2010.
16. Caroline Eisner. The Beginner’s Guide to Standard Operating Procedures - SOPs (Templates Included) [Internet]. 2022 [cited 2022 September 18]. MaintainX; Available from:
17. EFDA. SOP for document management and control. QA; 2022.
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