Reference Materials: An Introduction to Quality & its Importance in Reference Standard Selection and Use
sponsored by Merck
Thursday, June 18, 2020
11am EDT | 8am PDT | 4pm BST | 5pm CEST
Reference materials are a critical component of the laboratory’s quality system. From calibration of measurement systems to validation of methods, reference materials ensure accuracy in testing. Different terminologies between pharmaceutical (compendial) and non-pharmaceutical (ISO) reference materials can lead to confusion in determining the best fit-for-purpose reference, potentially impacting accuracy of the testing method. In this presentation, important concepts from metrological traceability, SI unit of measurement and certificate of analysis will be discussed along with the different quality grades of reference materials and how selection of the proper quality grade can ensure optimal fit-for-purpose and testing accuracy. Traceability, certification, stability, and workflow application examples will be provided.
Learning Objectives
- Understand important terms and concepts, such as metrological traceability, certificates of analysis, stability, and reference material certification techniques
- Recognize the different quality grades & formats of reference materials and their intended uses to establish proper selection criteria for use in a testing application
- Appreciate the impact of measurement errors due to improper selection of the reference material quality grade or poor fit-for-purpose