ICH Q9

Quality Risk Management Methods and Tools: Powerful Guide for Effective and Positive Risk Control

by

Quality Risk Management Methods and Tools: Powerful Guide for Effective and Risk Control Quality Risk Management Methods and Tools provide structured approaches for identifying, evaluating, controlling, communicating, and monitoring risks that may affect pharmaceutical products, processes, facilities, and systems. The purpose of Quality Risk Management Methods and Tools is not to require one specific technique … Read more

Quality Risk Assessment New Product Introduction: Non-Sterile Soft Gelatin Capsules

by

Quality Risk Assessment – New Product Introduction: Non-Sterile Soft Gelatin Capsules Objective: Identify, assess, and control quality risks before commercial manufacture of a new soft gelatin capsule product. 1. Formulation Risks API–excipient incompatibility API degradation / oxidation / hydrolysis Fill viscosity and uniformity Solubility and precipitation Over/under-fill risk 2. Gelatin Shell Risks Gelatin–fill interaction Shell thickness … Read more

Quality Risk Evaluation for New Product Introduction Non-Sterile Solid Oral Dosage Forms

by

Quality Risk Assessment for Solid Oral Dosage Forms Non-Sterile Solid Oral Dosage Forms 🎯 OBJECTIVEEvaluate and control quality risks before introducing a new solid oral dosage product to ensure patient safety, product quality, GMP compliance, and process robustness. 🔍 KEY RISK AREAS 1️⃣ Product & Formulation API/excipient compatibility CQAs: assay, dissolution, content uniformity, impurities API … Read more

Continual Improvement of the Pharmaceutical Quality System: A Practical FDA, ICH & PIC/S Framework

by

Continual Improvement of the Pharmaceutical Quality System: A Practical FDA, ICH & PIC/S Framework A pharmaceutical quality system should do more than demonstrate compliance. It should enable an organization to identify emerging risks, understand process performance, learn from quality events, and continuously improve its operations. For pharmaceutical manufacturers supplying the United States, continual improvement should … Read more