Sterility testing, parenteral dosage

Parenteral dosage forms require extensive testing of sterility and biological impurity contamination because of the high sensitivity of this administration route. These same sterility standards do not apply to solid and... 

All preservative systems for both parenteral and non-sterile dosage forms should meet the 3 log reduction at 14 days for bacteria., i.e., USP category I requirements. EP/BP Antimicrobial Effectiveness Testing would be run only if requested by the Marketing Group. 

Parenteral solutions are to be tested for absence of visible and non-visible particles and sterility as specified in the Ph. Eur. Furthermore, freedom from pyrogens or endotoxins and the uniformity of dosage units and content are stipulated (see Sect. 32.8). Suspensions should be easily resuspendable to ensure precise dosing and uniformity of the dose during administration. Parenteral emulsions should be homogeneous. 

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