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...
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 | May 17, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, QMS, Quality control (QC), Wheat
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:”Specificity is the ability to assess unequivocally the analyte in the presence of components...
by maheshbhuva | Nov 3, 2023 | 21 CFR, Uncategorized
21 CFR stands for Title 21 of the Code of Federal Regulations. It is a set of regulations issued by the United States Food and Drug Administration (FDA) that covers various aspects of regulatory requirements for pharmaceuticals, medical devices, food, cosmetics, and...
