Elizabeth Rivera, Technical Services Manager at STERIS revealed in her presentation at Pharam Expo, “The Process Lifecycle Model: A New Approach to Cleaning Validation,” the mindset in pharmaceutical manufacturing is shifting toward an approach in which continuous monitoring plays an important role, due in part to FDA Guidance for Process Validation General Principles and Practices (2011). She notes this shift to continuous monitoring helps ensure effective cleaning procedures.

Read more on the lifecycle approach that consists of three stages.