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 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...
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...
