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.
Although most organizations appreciate the importance of SOPs, they may have a poor
understanding of many aspects of SOP creation, maintenance, training and organization, leading to many errors with regulatory compliance identified during FDA audits. This article discusses the most common issues with SOP creation, management and implementation and suggests solutions to create one of the best regulatory compliance tools available to an organization.
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