MilliporeSigma - Reference Materials in Pharma QC

Building a strong foundation for your analytical workflow

Your results are only as accurate as your reference. Within Pharma QC, whether you are performing dissolution testing or releasing finished goods, having accurate, reliable and fully characterized Reference Materials is critical. This webinar will provide viewers with an overview of key concepts relating to Reference Materials.

With a multitude of suppliers serving the industry – both compendial and commercial – there are myriad choices of Reference Materials available for a quality control laboratory. We will discuss how different quality grades are “fit for purpose,” best practices in Reference Material production, and what to look for in a Reference Material Certificate of Analysis.

We will also discuss a novel concept: fully characterized Certified Reference Materials (CRMs) qualified against compendial standards. These CRMs are designed to replace a laboratories in-house working standards and pair with a laboratory’s primary Reference Standards to form a strong, well-characterized and fully traceable Reference Material foundation.

Key Learning Objectives

• Understand how different Reference Material quality grades are fit-to-purpose
• Provide key concepts in Reference Material manufacture and characterization
• Detail Certificate of Analysis (CoA) key attributes that will be common across sources

Audience

• Laboratory Directors
• Pharmaceutical Quality Control (QC) Managers
• Pharmaceutical Quality Control (QC) technicians

Presenter: Michael Hurst (Product Manager - Reference Materials)