Table 3.

Measures to Verify the Absence of Different Types of Contaminants (Examples)

Type of Contaminant	Measure to Verify the Absence of Contaminants in a Product Batch
Microbiological	– Bioburden test (in-process control)
	– Sterility test
Pyrogena	– Validation of depyrogenization (as part of the process validation)
Endotoxin	– Bacterial endotoxins (limulus amebocyte lysate) test
Residual contaminantsb	– Extended product characterization
	– Process validation
	– Manufacture under GMP
	– QC during batch release to confirm batch-to-batch consistency

^aThe formerly used rabbit pyrogens test has been replaced by the generally accepted bacterial endotoxins test in numerous EP monographs.¹¹

^bThe formerly used abnormal toxicity test has been deleted based on historical review in numerous EP monographs.^11,14