by maheshbhuva | Dec 5, 2025 | Analytical Chemistry, Deviation, Quality control (QC)
Detailed Breakdown ​1. Deviation ​Definition: Any departure from a written procedure, standard, or instruction. ​Types: ​Planned Deviation: A temporary, pre-approved change. (e.g., “We are out of Filter A, so we have permission to use Filter B for this batch...
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...
