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...
by maheshbhuva | May 21, 2026 | Analytical Chemistry, Quality control (QC)
En el competitivo entorno de las empresas farmacéuticas modernas, garantizar la calidad precisa del producto no es solo un requisito regulatorio: es la base de la seguridad del paciente. En el corazón de este aseguramiento de la calidad se encuentra el análisis HPLC...
by maheshbhuva | May 20, 2026 | Analytical Chemistry, Out of specification, Pharmaceutical interview,, Quality control (QC)
Can we average an OOS result with passing retest results to get a passing average? A: Absolutely not. Both FDA and MHRA guidelines strictly prohibit averaging an OOS result with passing retests to “hide” the failure or bring the batch into compliance....
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...
