ABSTRACT

OVERVIEW The inspection of parenteral products is driven by the need to minimize the introduction of unintended particulate matter to patients during the administration of injectable medications. Visual inspection also allows for the opportunity to detect and reject other categories of nonconforming units, such as those with cracks and or incomplete seals, which can affect the integrity and sterility of the product. In most cases, these defects will occur randomly and at low frequency. This has led to the current expectation that each finished unit will be individually inspected 100%.