Four Keys to Reference Standard Management

Ensuring Product Quality, Safety, and Potency for Pharmaceutical Manufacturers

The U.S. Food and Drug Administration (FDA) defines a reference-standard material as a “highly purified compound that is well characterized.” Reference standards are a cornerstone of the pharmaceutical industry, critical to assessing product quality, safety, and potency during product development. Throughout the drug development process, MRIGlobal can help ensure quality control in critical areas such as the release of new product batches and stability evaluation.

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Reference Standards in the Pharmaceutical Industry

Reliable reference standards are critical for confirming the safety and efficacy of drug substances and drug products. It is the sponsor’s responsibility to procure, qualify, and manage reference standards. To support development of a reference standard management program and help clear these hurdles, we’ve compiled some of the most frequently asked questions about reference standards in the pharmaceutical industry.

Analytical Method Transfer Validation

An area of expertise that supports reference standards is analytical method transfer (AMT). When a method is developed and validated at one laboratory, research scientists at MRIGlobal then test that method to prove that it can be run at a different laboratory. With our reference standard management programs, we are often transferring methods from several different laboratories to support standard requalification.

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Infectious Disease Diagnostics for Influenza, RSV and SARS-CoV-2

Tuesday, March 05, 2024 | 12pm EST

The need for rapid, accessible, and portable infectious disease diagnostics for seasonal respiratory diseases like influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 is critical to saving lives. Join an informative webinar focused on in vitro diagnostic development to meet this need, ranging from assay design, the use of bioinformatics in identifying emerging pathogens and optimizing assays, and securing the necessary regulatory approvals that support market access.