DESIGN, CONTROL, AND MONITORINGOFSINGLE-USE SYSTEMS FOR INTEGRITY ASSURANCE

DESIGN, CONTROL, AND MONITORINGOFSINGLE-USE SYSTEMS FOR INTEGRITY ASSURANCE
The risk management plan contains four key elements – Business, Product, Operator & Environment, and Integrity. The latter involves a Quality by Design (QbD) approach including a road map of the product life cycle to identify the quality attributes that are important for the achievement of system integrity. The guide highlights the importance of a shared responsibility by the supplier and end(user in the evaluation and implementation of the plan, and gives detailed recommendations on issues relevant to system integrity such as process validation, packaging, QC testing, installation, training, etc.