Module 3 - Strategic case studies in practice

Example-3  Oral IR tablet: EQ 5mg base  API loading: ~4%  Diluents: microcrystalline cellulose (~60%) and lactose monohydrate (~30%)  Other excipients: disintegrant and lubricant  Manufacturing Process: – blending, milling, blend lubrication – roller compaction and milling, blend lubrication – compression and aqueous based film coating  Content Uniformity is a high risk CQA 30