Table II.

Variables Which May Influence Product Quality

Product Quality Item	Process Variable
Appearance	Freeze-drying process
Reconstitution characteristics	Freeze-drying process
Content	Filling weight (IPC)
Content uniformity	Filling weight uniformity (IPC)
Purity	Purity API
	Processing time
pH after reconstitution	Concentration/characteristics of API and/or excipients
Residual moisture/solvent content	Freeze-drying process
Sterility	API/excipients/bioburden of formulation solution (IPC)
	Filter integrity (IPC)
	Clean room/personnel performance
Bacterial endotoxins	Contamination of API and/or excipients
	Clean room/personnel performance

IPC in-process control.