Quality Risk Evaluation for New Product Introduction Non-Sterile Oral Liquid Dosage Forms
Quality Risk Assessment for Solid Oral Dosage Forms for New Product Introduction OBJECTIVEEvaluate and control quality risks before introducing a new oral liquid product to ensure patient safety, product quality, process robustness, and GMP compliance. KEY RISK AREAS 1️⃣ Product & Formulation API–excipient compatibility Solubility / suspension characteristics CQAs: assay, pH, viscosity, microbial limits Preservative … Read more