Table 1.

Process Map (Lab-scale).

Process	Material	MAs	PPs	Associated CQAs
Mixing	API + co-former (EM) Disintegrants Fillers Surfactant	Particle size Flowability Uniformity Moisture content	Order of addition Hold time Environment (temperature and humidity)	Flowability Uniformity
Mixing	API + co-former (EM) Disintegrants Fillers Surfactant + Lubricant	Particle size Flowability Uniformity Moisture content	Order of addition Hold time Environment (temperature and humidity)	Flowability Compressibility Uniformity Disintegration Dissolution
Direct compresion	API + co-former (EM) Disintegrants Fillers Surfactant + Lubricant	Particle size Compressibility Uniformity	Compressor type Compression force Rotation speed Environment (temperature and humidity)	Appearance (Size and shape) Weight Thickness Hardness Friability Content uniformity Disintegration Dissolution