PDA Letter Article by Izi Bruker, MPH, PhD, Fellow, Clinical, Medical, and Regulatory Affairs at Kymanox Corporation

The United States (U.S) Food and Drug Administration’s (FDA) draft guidance on visual inspection states that the clinical manifestation of adverse events caused by particulate contamination depends on the route of administration, patient population and nature, size and shape of particulates, and chemical reactivity to certain cells or tissues.

While the call for injectable products to be free of any visible particle contamination has been described in the regulations, the varied probability of detecting particles during nondestructive inspection has also been officially recognized. Regulatory monographs in Europe and the U.S. require drug products for parenteral administration to be “practically free” or “essentially free” of visible particles, respectively. Both terms have been used interchangeably and acknowledge the probabilistic nature of visual particle inspection.

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