Analytical methods are developed and validated to meet customer and regulatory requirements. Over time these methods, which are established in production environments and routinely handling customer samples, may be considered for changes or have unexpected changes introduced too them. Supply chain shortages, more economical vendor alternatives, unexpected vendor changes, advances in technologies, desire for more efficient workflows are some reasons that can cause these changes.
Changes, no matter how small, may have an impact on method performance and it is vital to confirm when these changes are made, appropriate experiments are performed to show equal or greater method performance to ensure result quality is not compromised. This presentation will provide some recent examples of changes (attempted, planned and unplanned) and some of the experimental process used to evaluate changes. Examples will be given in hopes of bringing more awareness to the potential adverse and positive effects these changes can bring.
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