This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives. The new industrial revolution, “Industry 4.0,” ...

Q2 (R2) can also be applied to other analytical procedure used as part of the control strategy (Q8–Q10) following a risk-based approach (15), enlarging its scope to validate procedures to be used for ...

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 ...

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 ...

The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...

Dublin, Jan. 18, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. This Analytical ...

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 ...

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 ...

Dublin, Dec. 30, 2022 (GLOBE NEWSWIRE) -- The "Analytical Method Validation, Verification and Transfer [New Course]" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...