THE USE OF PROFICIENCY TESTING AS A TOOL FOR A ROBUST QUALITY MANAGEMENT SYSTEM IN A PHARMACEUTICAL LAB

Nicolas Hauser, Marketing, Merck KGaA, Laramie, WY 82070, USA (nick.hauser@milliporesigma.com)

Proficiency Testing (PT) is the name used by the International Standards Organization for a procedure also known as “inter-laboratory study” or “external quality assessment” or “ring test”. Proficiency testing, in simple terms, comprises a sample sent to a group of laboratories for measurement. The labs know what might be in the sample, but they don’t know exactly what is there or the concentration. Their results are compared with the known or true value and the lab is assigned a “Z” score to show how closely their result came to the target.

A major benefit of Proficiency testing is as a critical tool for quality assurance and continuous improvement. Proficiency testing performed over time can give a laboratory a true picture of their testing quality, it can help a laboratory identify and realize continual improvement opportunities and can actually help a laboratory avoid nonconforming tests.

Proficiency testing samples have specific analytes of interest, spiked in a particular matrix, in a concentration unknown to the participant. Proficiency testing samples are fully tested and characterized by the provider prior to shipment. Each Proficiency testing sample is supplied to the participant with a reporting packet which contains all of the critical information needed to perform the test such as the date range in which the test will be performed, instructions on how to report the data, any preparation or handling instructions, and the analyte ranges for the sample.

Pharmaceutical Proficiency testing samples are usually performed to demonstrate competency to Pharmacopoeia general chapters and are typically neat materials. Technology PTs are used to prove competence to a specified technology, such as titration, pH, Karl Fischer, or Residue on Ignition.

Presented here is a Proficiency testing platform and reporting results that was developed to allow for easy access to pertinent and historical data to allow the laboratory the opportunity to identify trends their testing rapidly. The laboratory’s requirements for accreditation and internal tracking were a focal point in the design of the PT system.

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Abstract Reference & Short Personal Biography of Presenting Author

Nicolas J. Hauser received a B.S. degree in Chemistry from St. Cloud State University in St. Cloud, MN. He completed a PhD degree in Analytical Chemistry from University of Wyoming in Laramie, WY. His focus during graduate school was method development for proteomics using mass spectrometry. Nick joined MilliporeSigma (formerly Resource Technology Corporation) in May 2008 and began work as an analytical chemist performing R&D and QC on RTC’s vast portfolio of products. Nick is currently a Product Manager in the Reference Materials Franchise for MilliporeSigma and oversees several products used in pharmaceutical analysis as well as proficiency testing.