by maheshbhuva | May 28, 2026 | 483 observation, ALCOA++, Analytical method development hplc,, Hplc, Job interview, News Pharma, Pharmaceutical interview,
STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements. 2. SCOPE...
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...
by maheshbhuva | May 25, 2026 | Analytical Chemistry, Analytical method development hplc,, GMP, ICH Guideline, Method validation, process validation, QMS, Quality control (QC)
The pharmaceutical and biotechnology sectors in New South Wales are experiencing an incredible boom. From the bustling research hubs in Macquarie Park and Westmead to the clinical trials happening across Randwick, local innovators are developing next-generation...
by maheshbhuva | May 23, 2026 | 21 CFR, Analytical Chemistry, Quality control (QC)
Escribir un Procedimiento Normalizado de Trabajo (PNT / SOP) no es solo plasmar palabras en un papel; es construir un escudo de cumplimiento para tu planta. Un PNT mal redactado es la causa directa de desviaciones, errores humanos y dolores de cabeza durante las...
