by maheshbhuva | Jun 5, 2026 | Analytical Chemistry, Hplc
If you run high-performance liquid chromatography (HPLC) assay, you know that consistency is everything. In a validated method, your retention time (RT) should remain rock-steady from injection to injection. But every chromatographer eventually faces that frustrating...
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 19, 2026 | Analytical Chemistry, Documents error (DIN), GMP, ICH Guideline, Out of specification, Pharmaceutical interview,, QMS, Quality control (QC)
An Out of Specification (OOS) investigation is a critical regulatory requirement in the pharmaceutical industry. When an analytical result falls outside the established specifications or acceptance criteria (defined in pharmacopoeias, drug applications, or internal...
by maheshbhuva | Apr 30, 2026 | Analytical Chemistry, Quality control (QC), Uncategorized
HPLC Fundamentals & Principles | Interactive Study Guide What is the basic principle of HPLC? The separation of components in a mixture based on their different distributive behaviors between a liquid mobile phase and a solid or liquid stationary phase. What are...
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...
