#21cfr

Operational excellence is demanded by modern quality control laboratories. Every single day, high testing volumes are managed by laboratory analysts. Accuracy must be maintained during complex testing procedures, including HPLC analysis and Karl Fischer titration. When workflows are optimized, regulatory compliance is easily achieved by pharmaceutical professionals.The Importance of Process…

STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements. 2. SCOPE This procedure applies to all CAPAs arising from all GxP activities within the organization including manufacturing, QC, QA,…

🚀 Building Compliant LIMS Software: Key Audit Trail FeaturesDesigning a pharmaceutical LIMS requires a relentless focus on data integrity, 21 CFR Part 11 compliance, and ALCOA+ principles. Here are the core audit trail features I’m prioritizing for our software modules:Immutable Metadata Logging: Automatically capturing the “Who, What, When, and Why” for every data entry, ensuring logs can never…

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 auditorías de la #MHRA o la #FDA. 🛡️Ya sea que estés redactando un procedimiento desde cero o revisando una actualización, aquí tienes…

FTIR METHOD DEVLOPMENT Fourier Transform Infrared Spectroscopy (FTIR) is widely used in analytical method development because it provides rapid, sensitive, and eco‑friendly characterization of pharmaceutical substances, excipients, and formulations. It is especially valuable for fingerprinting Active Pharmaceutical Ingredients (APIs) and validating methods without the need for solvents.  — …

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 weight in the world of medicine. Contrary to its technical appearance, this term is surprisingly simple to understand and represents one of the…

Prevent degradation and meet packaging standards effortlessly