The benefits are:
• Facilitated robustness of the manufacturing process, through facilitation of continual improvement through science and risk-based postapproval change processes
• Consistency in the global pharmaceutical environment across regions
• Enable transparency of systems, processes, and organizational and management responsibility
• Clearer understanding of the application of a quality system throughout product life cycle
• Further reducing risk of product failure and incidence of complaints and recalls, thereby providing greater assurance of pharmaceutical product consistency and availability (supply) to the patient
• Better process performance
• Opportunity to increase understanding between industry and regulators and more optimal use of industry and regulatory resources; enhance manufacturer’s and regulators’ confidence in product quality
• Increased compliance with GMPs, which builds confidence in the regulators and may result in shorter inspections.
