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...
by maheshbhuva | Jan 10, 2026 | Analytical Chemistry, Analytical method development hplc,, ICH Guideline, Method validation, Quality control (QC)
What a Wedding Day Can Teach You About Perfect Lab Results1. Introduction: The Universal Language of AnalogyHave you ever felt locked out of a conversation by technical jargon? Science, in particular, can feel like an intimidating world of its own. But the truth is,...
by maheshbhuva | Jan 3, 2026 | 21 CFR, Analytical Chemistry, QMS, Quality control (QC)
Introduction: Cracking the Code The pharmaceutical industry is filled with complex jargon and acronyms that can be intimidating to outsiders and newcomers alike. One term that frequently appears is “21 CFR,” a seemingly cryptic code that holds immense...
by maheshbhuva | Dec 19, 2025 | Analytical Chemistry, Analytical method development hplc,, QMS, Quality control (QC)
Incident Number: LAB-2025-012 Date of Incident: December 19, 2025 Product Name: Azithromycin (Finished Product) Batch Number: 33334562222 Test: Related Substances (RS) by HPLC Analyst Name: Anil Patel (ID: 5122) I. Incident Description During the HPLC analysis of...
by maheshbhuva | Dec 5, 2025 | Analytical Chemistry, Deviation, Quality control (QC)
Detailed Breakdown ​1. Deviation ​Definition: Any departure from a written procedure, standard, or instruction. ​Types: ​Planned Deviation: A temporary, pre-approved change. (e.g., “We are out of Filter A, so we have permission to use Filter B for this batch...
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...
