(198c) Blend and Content Uniformity for in-Process Control for Solid or Suspension Oral Dosage Form: Common Deficiencies and Case Studies from Drug Application Assessment

Drug substance homogeneity in finished drug product is one of the most important quality attributes for Solid or Suspension Oral Dosage Form. This homogeneity is commonly monitored through In-Process Controls (IPC) of blend uniformity (BU) and stratified content uniformity (stratified CU) during manufacturing and Uniformity of Dosage Unit during release for tablets, capsules, and oral suspensions. Inadequate control of content uniformity can lead to insufficient or excess content of active drug substance in the drug product, which can result in in-effectiveness or increased adverse effects, respectively. Inadequate content uniformity control is commonly observed during the review of the proposed control strategy in drug applications. This poster presents some examples of common BU/CU related deficiencies and case studies from drug applications submitted to the FDA.