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 ...

Analytical techniques for validating cleaning methods must evolve to match the pace of an increasingly complex manufacturing landscape for new therapeutics. Within the bio/pharma industry, there is a ...

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 ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Method validation is recognised as an essential part of good measurement practice. It cannot be guaranteed that analytical data will be fit-for-purpose unless the performance of the test method has ...

1. Understand the general principles and importance of method validation for biological analyses to obtain valid analytical results. 2. Understand the concept and importance of method performance ...

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 ...