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 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 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 | Apr 21, 2026 | 21 CFR, Analytical method development hplc,, Quality control (QC), wet lab
FTIR METHOD DEVLOPMENT Fourier Transform Infrared Spectroscopy (FTIR) is widely used in analytical method development because it provides rapid, sensitive, and eco‑friendly characterization of pharmaceutical substances, excipients, and formulations. It is especially...
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 | Jan 26, 2026 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC)
1. Define the Purpose and Scope Establish the method’s objective before you begin writing. Method Title: Assign a descriptive name (e.g., “HPLC Method for the Quantification of Paracetamol in Tablets”). Objective: State exactly what the method...
