by maheshbhuva | Jan 26, 2026 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC)
1. Define the Purpose and Scope Establish the method’s objective before you begin writing. Method Title: Assign a descriptive name (e.g., “HPLC Method for the Quantification of Paracetamol in Tablets”). Objective: State exactly what the method...
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 | Nov 23, 2025 | Analytical Chemistry, Deviation, QMS, Quality control (QC)
A sequence of 15 samples (ID: LIR-20251123-A) was being run for the quantitative analysis of [Specify Compound/Analyte] in [Specify Matrix, e.g., pharmaceutical tablet, environmental water sample]. The sequence included standards, blanks, and quality control (QC)...
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...
