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 ...

Intimate Connectivity Must Be Maintained Throughout the Product’s Lifecycle The link between product specifications and analytical methods throughout a product’s lifecycle makes intuitive sense. One ...

An international research team, with significant involvement from the Medical University of Vienna, has developed a new AI-based analysis method that can accurately classify brain tumors using genetic ...

In this GEN webinar Ray Zhang, PhD, associate director, QC-Analytics at Franklin Biolabs will introduce the principles of mass photometry and highlight where it adds value across the analytical ...

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 ...

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes. Pappa presented ...

If you’ve used gas chromatography-mass spectrometry (GC-MS) to analyze unknown compounds from cells and biological tissue, a new study suggests you may want to throw away most—if not all—of your data.

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 ...