by maheshbhuva | Jan 3, 2026 | 21 CFR, Analytical Chemistry, QMS, Quality control (QC)
Introduction: Cracking the Code The pharmaceutical industry is filled with complex jargon and acronyms that can be intimidating to outsiders and newcomers alike. One term that frequently appears is “21 CFR,” a seemingly cryptic code that holds immense...
by maheshbhuva | Dec 19, 2025 | Analytical Chemistry, Analytical method development hplc,, QMS, Quality control (QC)
Incident Number: LAB-2025-012 Date of Incident: December 19, 2025 Product Name: Azithromycin (Finished Product) Batch Number: 33334562222 Test: Related Substances (RS) by HPLC Analyst Name: Anil Patel (ID: 5122) I. Incident Description During the HPLC analysis of...
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...
by maheshbhuva | May 17, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, QMS, Quality control (QC), Wheat
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:”Specificity is the ability to assess unequivocally the analyte in the presence of components...
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...
