The latest NIR spectrometers for the pharmaceutical industry are designed to meet the stringent requirements of current good manufacturing practices (cGMP) and support 21 CFR Part 11 compliant processes. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA) (https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps). cGMP provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. According to the FDA, Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the FDA regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
Answer Id: E20672
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