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...
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...
