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ANALYTICAL METHOD ISSUES

This article was originally published in The Gold Sheet

Executive Summary

...are getting heightened attention as products and processes become more complex and approval timelines shrink. Industry is sharpening its focus on methods transfer, in particular, as a critical link in the CMC development chain. The comparability of HPLC columns, a mainstay in the analytical arsenal, is being explored. USP is looking to upgrade the compendial approach to heavy metal testing; industry is touting the advantages of new, more effective instrumental methods. With a better understanding of the QC implications of particle size, industry and FDA are working to improve related tests. The agency is also working with industry to clarify the essential elements of lab equipment qualification. [Recent warning letter citations involving analytical methods separated into four categories: -- method suitability -- method validation/transfer -- equipment calibration/qualification, and -- compendial issues are included.]
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