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 ...

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 ...

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 ...

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 ...

Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a ...

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.

To develop effective food control systems, regulatory bodies and laboratories in Member States must have the capability to apply sound sampling schemes and analytic methods. Our efforts focus on the ...