SOPs describe how to perform certain routine laboratory tests or activities normally not specified in detail in study protocols or test guidelines. The purpose of SOPs are primarily to ensure the quality and integrity of the data generated during the course of the study. The SOPs provide an essential foundation for the production of reliable data for decision making and regulatory purposes. Data can only be reliable if they result from use of known, standardized procedures, and are collected in a standardized way.  Thus, an SOP in an essential element in establishing and demonstrating such a reliability.  Technically valid and up-to-date SOPs are necessary for the generation of quality data. SOPs are the assets of a GLP organization.  They establish the credibility of the organization to the outside world about the commitment of Management towards GLP and the generation of high quality documentation. The SOPs should be used as practical tools. The SOPs have the same limitations as any other tools, functioning best in the skilled hands. The use of SOPs can entail pitfalls and surprises, and uncritical use can be a major risk to the data reliability. This presentation will spotlight the importance of developing technically sound SOPs and an effective SOP management system as practical tools for errorless compliance with GLP regulations.<br/>

Development of standard operating procedures (SOPs) and an effective SOP management system: Practical tools of GLP

256th National Meeting (2018)

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