RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance

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

Posted 01 October 2011 | By Mukesh Kumar

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.

 

© 2022 Regulatory Affairs Professionals Society.