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Samples in periodicals archive:
After introducing analytical method validation in general, they discuss analytical instrument qualification, high-performance liquid chromatography method development and optimization with validation in mind, method validation basics, robustness and system suitability, setting specifications and investigating out-of-specification results, validation by type of method, analytical method transfer, and implementing new technology in a regulated environment.
In parallel to USP <1058> on Analytical Instrument Qualification, there are three categories of "system" and, in an attempt to simplify validation, we get some silly issues that arise.
Suggested guidelines were recently published by the United States Pharmacopeia (USP) in a chapter, USP-NF <1058>, on analytical instrument qualification (15).
United States Pharmacopeia (USP) <1058> on Analytical Instrument Qualification (AIQ) is effective from August 2008.
NYSE: PKI), a global leader in Health Sciences and Photonics, today announced the acquisition of LabMetrix Technologies, the largest independent provider of metrology-based multi-vendor analytical instrument qualification solutions.
According to Iris Unterrieder of Baxter Bioscience, "[t]his IVT conference covers a broad spectrum of topics concerning quality in the lab- from GMP compliance, Change Control, and OOS cases to validation, analytical instrument qualification AIQ, and management of electronic records - every participant will find sessions to benefit from.