ICH Q12- Transforming Global Regulatory Post-Approval Submissions
Country-specific requirements and maintaining documents containing different quality information for the same product have always been challenging. Excessive inventory segregation, the likelihood of manufacturing and Regulatory compliance errors, and varying submission, evaluation, and deployment deadlines all add to the complexity of product supply chain regulation worldwide. As a result, various legal frameworks around the globe are focusing on implementing innovative modifications or enhancements to increase process efficiency and robustness.