Table I.

Selected Raw Material Attributes and Process Parameters

Name	Stage	Features (attributes and parameters)
S01–S21	Raw materials	Active pharmaceutical ingredient: particle size distribution (Malvern)
		Microcrystalline cellulose: loss on drying, sieve analysis (through 0.075 and 0.215 mm), conductivity
		Lactose: sieve analysis (through 0.250 and 0.100 mm), bulk volume, tapped volume, loss on drying
P01	Tablet strength	Tablet strength (four strengths, proportional tablet design)
P02–P15	High-shear wet granulation	Granulation parameters (two predefined parameter settings), nozzle spray pattern (narrow or wide), initial amount of granulation fluid, impeller torque after initial addition of granulation fluid, product temperature after initial addition of granulation fluid, additional amount of granulation fluid, impeller torque after additional amount of granulation fluid, impeller torque difference, final product temperature, difference between initial and final product temperature, total wet-massing time
P16-P25	Vacuum drying	Vacuum pressure, product temperature after initial drying phase, sieving mesh size, vacuum pressure of final drying phase, final product temperature, loss on drying, possible additional drying cycle with same parameters as the final drying phase, total drying time
P26–P29	Cooling	Vacuum pressure, product temperature, cooling time, yield
P30–P31	Sieving	Mesh size, yield
P32–P44	Tablet compression	Tableting speed, filling speed, main pressure, filling depth, normalized filling depth (dose-dependent), minimum punch gap, normalized minimum punch gap, de-dusting pressure, tablet press ID (multiple presses of same make and model), average tablet thickness, normalized average tablet thickness, tablet thickness variability, hardness, hardness variability, disintegration time (minimum, maximum).
Class		Batch quality class (1 = high, 2 = medium, 3 = rejected)