Objectionable organism

An organism that could harm patients or the product, considering its type, number, the product, the route of administration and the patient population. The idea goes beyond the pharmacopoeia's list of specified organisms. For example, Burkholderia cepacia complex is objectionable in oral liquids and nasal sprays even though it is not on the USP <62> list. Decisions are documented in a risk assessment and often reflected in product specifications.