Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...

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 ...

Analytical methods and tools play a pivotal role in cleaning validation. Validating the effectiveness of the cleaning of pharmaceutical manufacturing and process equipment is part of good ...

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 ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...

In-line UV spectroscopy allows real-time monitoring of cleaning processes, enhancing process control and compliance with Pharma 4.0 goals. The method provides continuous detection of residual cleaning ...

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 ...