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
Read also: CPP & CQA in Tablet ManuMasihuddin
Resource Person: Masihuddin Jaigirdar
