The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for ...
Analytical characterization is vital for product quality, manufacturing control, and regulatory compliance in biopharmaceutical development. ICH Q6B outlines structural characterization requirements, ...
The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based ...
The ICH Q12 guideline aims to harmonize post-approval change management, addressing delays and supply issues in the pharmaceutical industry. Global adoption is limited, with only three ICH countries ...
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