SUPAC IR guideline brief ( entry level for validation )

This video provides an overview of SUPAC-IR (Scale-Up and Post-Approval Changes – Immediate-Release Solid Oral Dosage Forms) and explains how SUPAC requirements can be applied for process validation and change assessment. The video will help you understand: • The different types of post-approval changes covered under SUPAC-IR • How to determine the applicable validation level based on the proposed change • The validation requirements associated with each level • How to assess the impact of manufacturing and scale-up changes • The relevant dissolution and documentation requirements • How to use the SUPAC-IR guidance to support a proper change-control assessment This video is intended to provide a practical understanding of how to determine the appropriate validation requirements and validation level for SUPAC-IR changes. #SUPAC #SUPACIR #ProcessValidation #Pharmaceutical #PharmaValidation #ScaleUp #PostApprovalChanges #QualityAssurance #GMP #RegulatoryAffairs