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Standard Operating Procedures (SOPs): Why Companies Must Have Them, and Why They Need Them

Abstract

This is the first of three articles on standard operating procedures or SOPs. It explains the role of SOPs and their maintenance. The second article will talk about what SOPs an organization needs to think about and how to determine what SOPs actually need to be in place. The last article will describe how to write SOPs in clear, concise language so that processes and activities occur as they are supposed to. SOPs are the first line of defense in any inspection, whether it be by a regulatory body, a partner or potential partner, a client, or a firm conducting due diligence for a possible purchase. It does not matter what a company calls them; any document that is a “how to” falls into the category of procedures. SOPs, in fact, define expected practices in all businesses where quality standards exist.

Learning Objectives

Upon completion of this activity, participants should be able to:

  • Explain the role of SOPs and the requirements for them

  • Describe the industry standards for generation, review, and approval of new and revised SOPs

  • Discuss industry best practices for maintaining an SOP system

Target Audience

This article is informative for all who work with all phases of therapeutic product development, manufacturing, and distribution. It is useful for people who make business decisions about operations.

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References

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    Hamrell MR, Wagman UK. Standard operating procedures in clinical research: a beginner’s guide. Qual Assur J. 2001;5:93–97

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    21 CFR §820.22(b). Quality audits.

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    21 CFR §11.10. Controls for closed systems.

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Author information

Affiliations

Authors

Corresponding author

Correspondence to Janet Gough MA.

Additional information

The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. This educational activity is designated for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activily.

If you would like to receive a statement of credit. you must review the article. and complete the posttest and evaluation included on the DIA website. Participants must receive a passing score of 80% or better on the posttest in order to receive a statement of credit. To access the posttest and evaluation. please visit the DIA website at www.diahome.org, select Educational Offrings, then select Continuing Education Jrom the drop-down menu, and the My Transcript link. This will take you to the My Transctipt page, where you will be prompted to sign in using your DIA username and password. Once signed in. you may select the Standard Operating Procedures (SOPs): Why Companies Must Have Them, and Why They Need Them link. You will be prompted to complete the posttest and evaluation. Upon successfil completion of the posttest, you will be able to download your statement of credit. If you are not a DIA customer, please contact the DIA office at mytranscript@diahome.org for a registration form. There is no fee to receive your statement of credit.

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Gough, J., Hamrell, M. Standard Operating Procedures (SOPs): Why Companies Must Have Them, and Why They Need Them. Ther Innov Regul Sci 43, 69–74 (2009). https://doi.org/10.1177/009286150904300112

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Key Words

  • SOP
  • Compliance
  • Procedure