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 ...

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 ...

An analytical method was validated for the quantitative determination of biogenic amines (BA) in agricultural products. Four agricultural foods, including apple juice, Juk, corn oil and peanut butter, ...

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 ...

A newly developed software program transforms written SOPs for all required analytical method validation experiments into transferable automated templates, integrating individual activities and ...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...

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 ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...