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Reference Materials – An Introduction to Quality & its Importance in Reference Standards Selection and Use
Innovation Manager, Reference Materials Franchise
Round Rock, TX, USA
Derrell Johnson joined Merck (formerly Cerilliant Corporation) in December 1999, and has over 19 years of experience in the reference standards industry from product development & management, sales & marketing and quality systems to manufacturing and quality control testing of reference materials. In his current role, Derrell is responsible for the evaluation of new analytical technologies and testing applications towards the development of new, innovative reference materials. He also supports management of the global Reference Materials business, leads the franchise’s custom business, and focuses on building collaborations & strategic alliances, both internal and external, to support and grow the business.
Derrell holds a Master of Science degree in Organic Chemistry from Texas A&M University and a MBA in Business Administration from Texas State University. He is an active member of AOAC International and an elected member of the Executive Committee for AOAC’s Technical Division of Reference Materials (TDRM).
From quality control testing of an active pharmaceutical ingredient to screening for adulterants in food, reference materials are a critical component of the laboratory’s quality system. Reference standards are offered across different quality grades from Certified Reference Materials (CRMs) and Reference Materials (RMs) to Analytical Standards and research grade materials. Along with the different quality grades, there also exists disparate terminologies between pharmaceutical (compendial) and non-pharmaceutical (ISO) reference standards. In this presentation, the differences among Reference Materials, Certified Reference Materials, Primary Standards, and Compendial Standards will be discussed as well as how CRMs and RMs are manufactured and certified under ISO 17034 and ISO 17025. Certification and testing examples will be provided to illustrate the importance of proper selection criteria and intended use of reference materials in analytical testing applications.