RAPS

ICH releases draft guidelines on analytical method development

ICH releases draft guidelines on analytical method development The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to ...
Business Wire

Validation, Verification & Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) - ResearchAndMarkets.com

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 ...
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 ...
Technology Networks

Automated Quality Control: Accelerating Lot Release with PCR Assays

Automated quality control using rapid PCR assays is replacing 28-day culture tests, cutting biopharmaceutical lot release ...