In the biotech industry, the integrity of documentation is just as critical as the product itself. Master Batch Records (MBRs) guide the execution of production steps, while Standard Operating Procedures (SOPs) define how those steps should be performed and documented. These two document types are deeply interconnected, and any misalignment between them can lead to compliance gaps, inefficiencies, or audit findings.
For many organizations, keeping MBRs and SOPs perfectly synchronized is an ongoing challenge. MBRs may unintentionally duplicate procedural instructions better suited for SOPs, miss key parameters, or reference outdated or irrelevant SOPs. Traditional manual reviews to catch these issues are time-consuming, error-prone, and difficult to scale—especially when documentation libraries span thousands of pages.
This was exactly the scenario one of our clients faced. They needed a way to systematically detect and correct inconsistencies between their MBRs and governing SOPs—without disrupting existing systems or exposing sensitive data to external networks.
The challenge:
The client wanted to ensure their MBRs were aligned with the governing SOPs that define how production steps should be executed and documented. Their main concerns:
• Are we duplicating procedural content in the MBRs?
• Are all parameters fully specified and traceable?
• Are we referencing the right SOPs in the MBRs?
Our Approach:
Our AI powered service securely deployed the review of documents entirely offline, using natural language understanding to compare MBRs and SOPs. No integration into the client’s environment was required.
MBR vs SOP Contradictions – Summary Reference Table
| Check Type | Objective | What We Checked | Common Findings |
| 1. Redundancy Check | Clarify what belongs in the MBR vs. what should stay in the SOP | – Reviewed each MBR step for: • Recording fields (blanks/boxes) • Action verbs like “record,” “calculate,” “determine” • Procedural-only steps without recording | – Redundant steps without fields cluttered the MBR – References to SOPs with missing steps |
| 2. Parameter Gap Analysis | Ensure all parameters are fully defined and traceable | – Extracted all parameters from MBR spec sections – Checked for: • Defined value or range • Units (e.g., °C, g, min) • Appearance in procedure • Recording instructions | – Parameters lacked units or tolerances – Some weren’t used in procedures – No recording for some critical data |
| 3. Reference Disconnect | Confirm MBRs reference only valid parent SOPs | – Extracted all “per SOP” references – Cross-checked against designated parent SOP categories (e.g., upstream, downstream, formulation) | – References to unrelated SOPs (e.g., admin, equipment) – Use of child or cross-process SOPs |
By running a focused contradiction check between their selected MBRs and the corresponding SOPs, the client was able to identify and address key areas of misalignment—improving documentation quality without changing existing systems.
The Results:
As part of this, the following improvements were made:
- We helped streamline their documentation by identifying and removing redundant procedural content from MBRs. These were steps that didn’t involve any recording or calculation and were better suited to the SOPs. The result? Cleaner, shorter MBRs that were easier to follow and less prone to confusion during execution.
- We uncovered parameter gaps—things like missing units, undefined ranges, or tolerances that weren’t recorded properly. By addressing these, the client improved the traceability between what was specified and what was actually documented during manufacturing. That meant stronger data integrity and smoother batch reviews for QA.
- We cleaned up references in the MBRs to ensure they only pointed to relevant, parent SOPs. Outdated links to admin procedures or unrelated equipment SOPs were removed. This brought the documentation into tighter alignment with regulatory expectations, making it easier to defend during audits and inspections.
Altogether, the client walked away with documentation that was more compliant, easier to use, and ready for regulatory scrutiny—all without disrupting existing systems.
This use case demonstrates that AI-powered analysis can transform checks between documents (e.g. MBR vs SOP) into strategic improvements.
With biotech and pharma companies managing complex documentation ecosystems, MBR/SOP contradiction checks are no longer a burden—they’re an opportunity.