by maheshbhuva | Jan 10, 2026 | Analytical Chemistry, Analytical method development hplc,, ICH Guideline, Method validation, Quality control (QC)
What a Wedding Day Can Teach You About Perfect Lab Results1. Introduction: The Universal Language of AnalogyHave you ever felt locked out of a conversation by technical jargon? Science, in particular, can feel like an intimidating world of its own. But the truth is,...
by maheshbhuva | Dec 4, 2025 | 21 CFR, Analytical Chemistry, Deviation, ICH Guideline, Quality control (QC)
1. EDQM / EU GMP (Europe) ​Focus: The European approach places heavy emphasis on the Qualified Person (QP). The QP acts as the gatekeeper and must personally ensure that any deviation does not violate the Marketing Authorization (MA). ​Risk Management: EU GMP...
by maheshbhuva | May 21, 2025 | Analytical Chemistry, ICH Guideline, QMS, Quality control (QC)
Understood. “Analytical image method validation” refers to the process of ensuring that image-based methods used for quantitative or qualitative analysis consistently produce reliable, accurate, and fit-for-purpose results. This is crucial in fields like...
by maheshbhuva | Dec 20, 2022 | ICH Guideline
What is ICH Guideline? ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical stability guidelines for industries. ICH stability guidelines for stability conditions and testing are followed throughout the world for...