How Does An SOP Differ From A Batch Production Record?

What is an SOP?

• Per ICH(International Council on Harmonization), an SOP is a detailed, written instruction to achieve uniformity of the performance of a specific function. They are informed by the guidelines of regulators (FDA, CDPH, etc.) as pertains to the organization and personnel, facilities, equipment and controls

What is an EBR?

• Electronic Batch Records provide the structure and means for automatically compiling batch production data into an electronic format. They contain the operational steps and reporting capabilities offering a detailed, retrievable capture of information about the product being made.

Why are SOP’s important?

• SOP’s direct and provide a check on work related activities according to the regulated guidelines. Work performed in violation of SOP’s is done at risk of sanction by the regulators

Why are SOP’s confused so often with EBR?s

• Both SOP’s and EBR’s are activity-based, and firms typically aim to standardize production worksteps; however, the SOP’s are based on regulations, not operations. Moreover, the EBR’s must conform to applicable SOP’s.

What makes an SOP most effective?

• Consistency of format
• Brief, but descriptive summaries
• Cross references to other SOP’s as needed
• Clear descriptions
• Assignments of responsibilities
• Sufficient detail about tasks that need to be done to satisfy the guidelines

What makes an EBR most effective?

• Production resource visibility and control at the EBR level through integration
• Configurability at both the overall and individual step level
• Compliance to 21 CFR Part 11, electronic documentation
• Integration with a quality system for coordinated deviation resolution