What is meant by a “risk-based approach” to GMPs? What are the most important consequences of this approach?
What is meant by a “risk-based approach” to GMPs? What are the most important consequences of this approach?
Good Manufacturing Practices Good Manufacturing Practices (GMPs) consist of guidelines and processes that govern the production and manufacture of drug products to assure that the drugs are safe, effective, and of consistently high quality. GMPs cover virtually every aspect of production and are not merely recommendations. Compliance is required by the FDA. To prepare for this Discussion, review the Learning Resources that explain GMPs and what is involved in taking a risk-based approach to their implementation. By Day 4, post a comprehensive response to the following: What is meant by a “risk-based approach” to GMPs? What are the most important consequences of this approach? How do you think it has changed (or will change) the way that medical products are brought to market?