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 | 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 | Apr 9, 2023 | Deviation, Documents error (DIN), QMS
Why investigation? To identified error  Random error Impacts precision (Weight error dilution  error injection to injection error Example document error, document error [ note : Precision show random error which is not control for us] +- positive and negative error...
by maheshbhuva | Feb 6, 2023 | Analytical Chemistry, Deviation, Documents error (DIN), Pharmaceutical interview,, QMS
Wet Lab analyst do Error ! Wet lab analyst are forgot a taken out of LOD or sulphated Ash, weight forgotten, etc ! . Some dilution error !. Weight print are not past in work sheet OR analytical work report or protocol etc (whatever terminology used). ! Calibration...
by maheshbhuva | Dec 10, 2022 | Analytical Chemistry, Deviation, Documents error (DIN), Out of specification, Pharmaceutical interview,, QMS
DIN (documents incident) IncidentDeviationOOS DIN Documentary error like miss date and sign, entry missed in logbook, Incident Like power failure, peak shape not properly, baseline not properly et OOS Results was not found as per specification Share this: Click to...
