The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

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 ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that ...

Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s ...

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. The US Pharmacopeial Convention (USP) released a general ...