PharmTech

Predictive modelling: putting ICH guidelines to work in process validation

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH ...
Yahoo Finance

3hr Virtual Seminar: Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH

Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...
RAPS

EMA Opens for Consult ICH M10 Guideline on Bioanalytical Method Validation

The European Medicines Agency (EMA) on Thursday released for public consultation the International Council of Harmonisation’s (ICH) M10 guideline, which aims to help sponsors improve the quality and ...
PharmTech

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

No additional expectations or mandated requirements are expected in Q14, Q2(R2) and USP <1220>. The minimal approach can still be used. Q14 and Q2(R2) are consistent with the principles described in ...
RAPS

FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines

The US Food and Drug Administration (FDA) on Wednesday issued two draft International Council for Harmonisation (ICH) guidelines covering safety data collection and bioanalytical method validation for ...