Why blending validation is required? What quality parameters of product are considered for validation and what parameters of equipment are to be considered during validation? : Pharmaceutical Guidelines

Why blending validation is required? What quality parameters of product are considered for validation and what parameters of equipment are to be considered during validation?

Interview Question #059
Blending validation is required to provide sufficient documented evidence to assure that the blending operation of the product is capable to mix the material repeatedly and reliably producing a homogeneous material to meet established specifications when operated under defined standard operating conditions.
The following Quality parameters are to be considered, but not limited:
  1. Loss on Drying/ Water content
  2. Bulk density/ tapped density
  3. Residual solvent
  4. Particle size
The following parameters are to be considered for the equipment during validation, but not limited:
  1. Blender capacity
  2. RPM of the blender
  3. Occupancy of the blender
  4. Number of individual batches to be taken for each blend
  5. Mixing time



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