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 | Dec 1, 2025 | Analytical Chemistry, Out of specification, Pharmaceutical interview,, Quality control (QC)
The OOS FlowchartPhase I: Laboratory Investigation(Did the Lab make a mistake?) [ START: OOS Result Detected ] | v[ Notify Supervisor Immediately...
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 | Oct 10, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC), wet lab
Specificity analytical method validation creative way to understand Imagine analytical method validation as building a highly specialized “detection machine” for a specific target. Specificity is about ensuring your machine only detects your intended...
by maheshbhuva | Jul 26, 2025 | Analytical Chemistry, Quality control (QC), Titration, wet lab
Imagine you’re a detective, and your mission is to find out exactly how much of a sneaky, hidden chemical called an “oxidizing agent” is present in a mysterious solution. You can’t see it, you can’t smell it, but you know it’s...
by maheshbhuva | Jul 22, 2025 | Analytical Chemistry, Quality control (QC), Titration
Complexometric titration, also known as chelatometry, is a type of volumetric analysis that relies on the formation of a colored complex to indicate the endpoint of a titration. This method is particularly useful for determining the concentration of metal ions in a...
