Tests for holding time study at different Manufacturing Stages in Pharma

   Examples of stages and tests that may be considered for hold time study based on risk  assessment and specific product needs:

Stage	Examples of tests to be considered
Dispensed materials storage Microbial test	Microbial test
Solutions prepared (including granulating pastes, coating solutions and coating suspensions)	Physical appearance Specific gravity Viscosity Sedimentation pH Microbial test
Granules	Description Assay Loss on drying Water content Particle size distribution Bulk density Tap density Angle of repose
Blend	Microbial test Moisture content Blend uniformity Particle size Bulk/tapped density
Core tablets – uncoated (In bulk containers)	Description Hardness Thickness Friability Appearance Dissolution Disintegration Assay Degradation products/related substances (where applicable) Uniformity of dosage Units Microbial test
Coated tablets (in bulk containers)	Description Hardness Thickness Friability Appearance Dissolution/dissolution profile Disintegration Assay Degradation products/related substances (where applicable) Uniformity of dosage units Moisture content Microbial test