Critical material attribute (CMA)

is a physical or chemical or microbiological property which variability has an impact on the critical quality attribute and therefore it should be monitored or controlled to ensure desired drug product quality.


A List of Critical Material Attributes in Pharmaceutical Manufacturing

Blending/ Mixing

  • Particle size
  • Particle size distribution
  • Fines/Oversize
  • Particle shape
  • Bulk/Tapped/True density
  • Cohesive/Adhesive properties
  • Electrostatic properties
  • Moisture content


Size Reduction/ Comminution/ Milling

  • Particle/Granule size
  • Particle/Granule size distribution
  • Fines
  • Particle/Granule shape
  • Bulk/Tapped/True density
  • Adhesive properties
  • Electrostatic properties
  • Hardness/Plasticity
  • Viscoelasticity
  • Brittleness
  • Elasticity
  • Solid form/Polymorph
  • Moisture content
  • Granule porosity/density

Wet Granulation

  • Particle size distribution
  • Fines/Oversize
  • Particle shape
  • Bulk/Tapped/True density
  • Cohesive/Adhesive properties
  • Electrostatic properties
  • Hardness/Plasticity
  • Viscoelasticity
  • Brittleness
  • Elasticity
  • Solid form/polymorph
  • Moisture content

Drying

  • Particle size, distribution
  • Fines/Oversize
  • Particle shape
  • Cohesive/Adhesive properties
  • Electrostatic properties
  • Hardness/Plasticity
  • Viscoelasticity
  • Brittleness
  • Elasticity
  • Solid form/polymorph
  • Moisture content

Roller compaction/ Chilsonation

  • Particle size, distribution
  • Fines/Oversize
  • Particle shape
  • Cohesive/Adhesive properties
  • Electrostatic properties
  • Hardness/Plasticity
  • Bulk/Tapped/True density
  • Viscoelasticity
  • Brittleness
  • Elasticity
  • Solid form/polymorph

Extrusion-Spheronization

  • Particle size, distribution
  • Fines/Oversize
  • Particle shape
  • Cohesive/Adhesive properties
  • Electrostatic properties
  • Hardness/Plasticity
  • Bulk/Tapped/True density
  • Viscoelasticity
  • Brittleness
  • Elasticity
  • Solid form/polymorph

Hot Melt Extrusion

  • Particle size, distribution
  • Fines/Oversize
  • Particle shape
  • Melting point
  • Glass Transition Temp.
  • Density
  • Solid form/polymorph
  • Moisture content

Tableting

  • Particle/granule size and distribution
  • Fines/Oversize
  • Particle/Granule shape
  • Cohesive/adhesive properties
  • Electrostatic properties
  • Hardness/Plasticity
  • Bulk/Tapped/True density
  • Viscoelasticity
  • Brittleness
  • Elasticity
  • Solid form/polymorph
  • Moisture

Encapsulation

  • Particle/Granule size and distribution
  • Fines/Oversize
  • Particle/Granule shape
  • Cohesive/Adhesive properties
  • Electrostatic properties
  • Hardness/Plasticity
  • Bulk/Tapped/True density
  • Viscoelasticity
  • Brittleness
  • Elasticity
  • Solid form/polymorph
  • Moisture

    Pan Coating

    • Tablet dimensions
    • Tablet defects
    • Hardness/Plasticity
    • Density
    • Porosity
    • Moisture content

    Fluid Bed Coating

    • Tablet dimensions
    • Tablet defects
    • Hardness/Plasticity
    • Density/Porosity
    • Moisture content

    Laser Drilling

    • Tablet size/dimensions
    • Polymer type
    • Membrane thickness


    Resource Person: Masihuddin Jaigirdar

    Tags in: critical material attributes in tablet manufacturing, critical quality attributes in tablet manufacturing, critical material attributes in granulation, examples of critical material attributes.