The Food and Drug Administration (FDA) uses the term ” nonconforming material” to describe products in manufacturing that do not meet specified requirements or established standards. This encompasses raw materials, components, in-process goods, and finished products that deviate from the defined quality criteria. For instance, a batch of pharmaceutical tablets with an incorrect dosage, or a medical device failing to meet performance specifications, would be classified under this designation.
Addressing deviations from established standards is critical for ensuring patient safety and product efficacy. Effective management of these materials minimizes risks associated with defective or substandard products reaching the market. Historically, robust procedures for identifying, segregating, and dispositioning these materials have evolved alongside increasingly stringent regulatory requirements and advancements in manufacturing technology. This evolution reflects a commitment to continuous improvement in quality control and adherence to Current Good Manufacturing Practice (CGMP) regulations.
