CPP and CQA in Different Stages of Drug Product Manufacturing

 


Critical Process Parameters (CPP), Critical Quality Attributes (CQA) & It's Stages

1) Wet Granulation

  • CPP: Mixing Time, Impeller Speed, Temperature, Binder Fluid addition Rate & Time, Method of Binder addition.
  • CQA: Moisture Content, Blend Uniformity, Granule Size & Distribution.


2) Drying

  • CPP: Drying Time, Inlet air flow, Exhaust air temperature & flow.
  • CQA: Moisture Content, Bulk/Tapped Density, Granules Strength & Uniformity.


3) Milling

  • CPP: Milling Speed, Screen Size, Feeding Rate.
  • CQA: Bulk/Tapped Density, Flow Properties, Particle Size Distribution.


4) Mixing

  • CPP: Mixing Time, Mixer Type, Order of Addition.
  • CQA: Blend Uniformity.


5) Compression

  • CPP: Pre Compression Force, Main Compression, Ejection Force, Dwell Time, Hopper Design, Roller Type, Punch Penetration Depth, Auger Screw Rate.
  • CQA: Weight Variation, Hardness, Frability, DT, Dissolution, Assay, Content Uniformity.


6) Coating

  • CPP: Time, Temperature, Inlet Air Flow, Spray Pattern & Rate.
  • CQA: Appearance, Thickness, Hardness, % of Weight Gain.

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