by maheshbhuva | May 19, 2026 | Analytical Chemistry, Documents error (DIN), GMP, ICH Guideline, Out of specification, Pharmaceutical interview,, QMS, Quality control (QC)
An Out of Specification (OOS) investigation is a critical regulatory requirement in the pharmaceutical industry. When an analytical result falls outside the established specifications or acceptance criteria (defined in pharmacopoeias, drug applications, or internal...
by maheshbhuva | Mar 26, 2026 | Analytical Chemistry, Analytical method development hplc,, Hplc, Hplc column, Pharmaceutical interview,, Quality control (QC)
HPLC column HPLC columns are classified in the United States Pharmacopeia (USP) under the “L” designation system, with each type assigned a specific USP code (e.g., L1, L3, L7). The main USP chapter that governs chromatography, including HPLC columns, is USP...
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 | May 31, 2023 | stability
It’s 60℅ Rh because (100 – 60 = 40 ℅ loss water (100-90 = 10 ℅ loss water Here 100 is in side containers water Inside container concentration might be different but, it’s water remain 100 ℅ Share this: Click to share on Facebook (Opens in new window)...
by maheshbhuva | Jan 5, 2023 | Analytical Chemistry, Method validation
• the requirements of the measurement procedure• scope of experiments• RM to be used• Equipment• Statistical tools to be used• personnel for performing experiments and evaluating obtainedresults Analytical method validation Share this: Click to share on Facebook...
