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 ...

The new industrial revolution, “Industry 4.0,” has been leading to changes in the pharmaceutical industry (“Pharma 4.0”), where significant paradigm shifts have been occurring in the pharmaceutical ...

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 ...

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 ...

Dublin, Dec. 04, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...

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 ...