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Red Nucleus Training Institute

Providing on-demand training solutions

Batch Records & Batch Record Review

Batch Records & Batch Record Review

Batch Records & Batch Record Review

~0.50 hrs | GMP - Quality Systems

The details documented in batch production records provide a complete picture of the manufacturing and testing processes. As a result, batch records are the most highly viewed records in regulatory inspections and audits. This module will explore batch record content, requirements, and review mechanisms to ensure compliance with global mandates.

Module Details

After completing this module, you will be able to:
• State what a batch production record is and why it is important to product quality and patient health
• Identify what should be included in a batch record
• Recognize specific roles and responsibilities of personnel involved in preparing, reviewing, and approving batch records
• List the expectations for a batch record review


• Audio narration with on-demand full-text transcript
• Module-level interactive learning exercises and
self-check questions
• Fully cited and sourced from a blend of Red Nucleus
best practices and global health authority regulations
and guidance
• Updated annually
• SCORM compliant

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