Using AI in Pharma Visual Inspection: Benefits & Challenges
Visual inspection in the pharmaceutical industry is a critical quality control step. Pharma visual inspection is a systematic examination of pharmaceutical products (often 100% of units) to identify visible defects before release. It is primarily applied to sterile...
Self-Inspection in Pharma Companies: What to Look For?
Self-inspection in pharma companies is a planned, systematic internal audit process aimed to evaluate processes, facilities, and systems. It is designed to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality...
US FDA Premarket Approval: Your Comprehensive Guide
FDA has three types of regulatory pathways, namely 510(k), De Novo, PMA, for medical device approval. US FDA premarket approval (PMA) is the most rigorous and stringent regulatory pathway. High-risk devices (Class III devices that sustain life or pose significant...