Why Chromatography Matters
Chromatography is one of the most critical analytical tools in pharmacopeial testing, playing a vital role in ensuring the quality and safety of pharmaceutical products. With the ongoing revision of USP <621>, aimed at modernizing methods and achieving international harmonization, these changes carry significant implications for both Quality Control (QC) and regulatory agencies alike.

Key Revisions in USP <621> Chromatography
The revisions to USP <621> align chromatographic methods with those of the European and Japanese Pharmacopoeias (Ph. Eur./JP), ensuring global harmonization in system suitability requirements.

Major changes include:

• Half-height Measurements: Resolution and plate number are now calculated using half-height measurements instead of tangent width.
• Terminology Update: The term “tailing factor” is now referred to as the “symmetry factor,” reflecting a more precise characterization.
  
• Signal-to-Noise Ratio: The S/N ratio is calculated using a noise range equal to five times the half-height peak width, enhancing analytical accuracy.

These revisions also provide greater flexibility in gradient methods, simplifying method transfer and modernization.

What’s Coming Next (Effective June 1, 2026)
On September 25, 2024, the USP announced a Notice of Intent to revise subsections on System Sensitivity and Peak Symmetry:

• System Sensitivity: This applies only to impurity tests with a defined reporting threshold in the monograph.
• Peak Symmetry: Relevant to Organic Impurities, Related Substances, and Assay methods, but not applicable if %RSD is already defined as a system suitability criterion.

QC System Upgrade at Bora Biologics
In our continuous quality improvement efforts, the Bora Biologics Quality Control (QC) department has successfully upgraded its Waters Empower Enterprise system to version 3.8.0, completing qualification in Q4 2024 to align with the latest USP <621> revisions.

This upgrade, alongside a Windows OS update, enables our QC laboratory to meet both information security and data integrity requirements. Given the critical importance of cybersecurity in pharmaceutical operations, our IT team remains committed to ongoing improvements organization-wide.

Benefits of the Upgrade

• Data Integrity: Enhanced through validated algorithms that minimize manual intervention.
• Regulatory Compliance: Seamlessly aligned with evolving global standards, which reduces audit risks.
• QC Efficiency: Increased automation and consistent reporting allow scientists to focus on science rather than administrative tasks.

Our Commitment
At Bora Biologics, we believe that continuous investment in and optimization of our laboratory data systems is fundamental to ensuring product quality and maintaining trust among patients and healthcare professionals worldwide. This upgrade marks another milestone in our ongoing commitment to exceptional quality and regulatory compliance—because at Bora Biologics, quality is not just a goal; it’s our promise.

About the Author

Allen Chen is a Senior Supervisor in Quality Control at Bora Biologics, bringing nearly 10 years of quality control experience across both small-molecule drug manufacturing and large-molecule biopharmaceuticals. With a Master’s degree in bioengineering, Allen is dedicated to upholding the highest standards of quality and compliance within the organization. He has developed specialized skills in raw material testing, in-process control, API/drug substance release, and QC laboratory management. His expertise in biopharmaceutical processes and commitment to continuous improvement play a vital role in advancing Bora Biologics’ mission to deliver exceptional biologics products.