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.
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
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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21 CFR §820.22(b). Quality audits.
21 CFR §211.180(e) (b). General requirements.
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21 CFR §11.10. Controls for closed systems.
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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