Webinar: Next Gen QMS: Quality, Risk & Compliance Unified Through AI

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Webinar: Next Gen QMS: Quality, Risk & Compliance Unified Through AI

SOP (Standard Operating Procedure)

Definition

A Standard Operating Procedure is a documented, standardized set of instructions describing how a specific task or process should be performed. SOPs are referenced throughout the EBR to guide operators through execution steps and are themselves subject to document control requirements.

Benefits

Linking relevant SOPs directly within the EBR, rather than requiring operators to separately locate a paper or PDF copy, ensures the correct, current version is readily accessible at the point of use, reducing the risk of an operator referencing an outdated procedure.

Use Case

An operator executing a cleaning step within the EBR clicks a linked reference to the current approved cleaning SOP directly from the batch record interface, ensuring they're following the exact, currently approved version rather than a printed copy that may be out of date.

Frequently Asked Questions (FAQ)

  • An SOP describes how to perform a general task or process (like equipment cleaning), while an MBR is product-specific, providing the full formula, specifications, and instructions for manufacturing a particular product.

  • Yes. SOPs are subject to the same document control and change management rigor as MBRs, since operators must always be working from the current approved version.

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