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 | Jun 13, 2026 | Analytical Chemistry, Newsletter, Nitrosamine, Quality control (QC)
* Nitrosamines are trace chemical impurities. * They are classified as probable human carcinogens. * Global agencies require a strict 3-step risk assessment framework. * Manufacturers must evaluate, test, and fix any impurity risks.1. The Global CPCA SystemAgencies...
by maheshbhuva | Jun 10, 2026 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC)
Specificity This concept is essential in scientific analysis. When you create a method to measure something (like a drug or a chemical), you must prove that the method only measures that specific substance and isn’t being ‘fooled’ by other things in...
by maheshbhuva | Jun 2, 2026 | Analytical Chemistry, Analytical method development hplc,, Quality control (QC)
Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use. Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for...
by maheshbhuva | May 26, 2026 | Analytical Chemistry, Audit Trail, Quality control (QC)
🚀 Building Compliant LIMS Software: Key Audit Trail FeaturesDesigning a pharmaceutical LIMS requires a relentless focus on data integrity, 21 CFR Part 11 compliance, and ALCOA+ principles. Here are the core audit trail features I’m prioritizing for our software...
by maheshbhuva | May 26, 2026 | Analytical Chemistry, ICH Guideline, Quality control (QC)
🌍 Harmonizing Pharmaceutical Quality Testing: ICH Q4 GuidelinesThe International Council for Harmonisation (ICH) Q4 series is a milestone in global regulatory collaboration. 🔹 Core Guideline (Q4B): Establishes the process for evaluating pharmacopoeial texts...
