Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories. The complete or partial revalidation of the ...

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. etrmalinak/shutterstock.com The US Pharmacopeial Convention ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Thin-layer chromatography (TLC) was widely used in the 1960s and 1970s for pesticide residue analysis, but only to a limited extent since gas–liquid chromatography (GLC) and high performance liquid ...

Dublin, Dec. 30, 2022 (GLOBE NEWSWIRE) -- The "Analytical Method Validation, Verification and Transfer [New Course]" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...