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 ...

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The Role of Analytical Method Development in CRDMO SuccessWhy Analytics Is a Pillar of Pharmaceutical DevelopmentIn today’s ...

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

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 ...

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. etrmalinak/shutterstock.com The US Pharmacopeial Convention ...