SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance

Posted 01 October 2011 | By Mukesh Kumar, PhD 

Written standard operating procedures (SOPs) are the foundation of any drug development, testing, manufacturing and marketing program. SOPs strengthen compliance not only with US Food and Drug Administration (FDA) requirements but also with international requirements. Ideally, SOPs should describe everything that occurs at a facility in sufficient detail to ensure all tasks are conducted consistently, repeatedly and accurately. SOPs are among the first documents to be reviewed by auditors and are an integral component of an organization's demonstrated compliance with regulations.

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