by maheshbhuva | Jun 15, 2026 | Analytical Chemistry, Documents error (DIN), Out of specification, Pharmaceutical interview,, QMS, Quality control (QC)
RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES AS PER REGULATORY REQUIREMENTS 1. PROBLEM IDENTIFICATION What Happens Clearly define the deviation, OOS, OOT, complaint, breakdown, audit observation, or incident. Includes Deviation description Date & time...
by maheshbhuva | May 16, 2026 | Hplc, Hplc column, HPLC VIAL, Job interview, Pharmaceutical interview,, Quality control (QC)
In the competitive landscape of modern pharmaceutical companies, ensuring precise product quality isn’t just a regulatory requirement—it is the foundation of patient safety. At the heart of this quality assurance is HPLC analysis (High-Performance Liquid...
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 | 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...
