Drug Inspections and Compliance: Current Good Manufacturing Practice (CGMP)

Current Good Manufacturing Practice (CGMP) inspections and compliance Inspections help ensure the safety and quality of drugs The FDA is committed to ensuring that the medicines available to hospitals, health systems and patients are safe, effective and of reliable quality. For products that require a marketing application — usually prescription drugs — the FDA's approval process is the first step. The FDA's approval of a drug application includes assessing the manufacturing process and production facilities, and considering information obtained through inspection or alternative tools, to ensure that the proposed manufacturing process can meet applicable standards and produce high-quality drugs. In addition, the FDA oversees the safety and quality of drugs marketed without an approved application, including over-the-counter monograph products and compounded drugs. All drugs manufactured for the U.S. market must meet FDA's rigorous standards The FDA monitors drugs on the market to help ensure they meet FDA requirements for safety and quality, whether or not they are application drugs. All drugs manufactured for the U.S. market, whether produced domestically or overseas, must meet the same rigorous standards. Industry has a responsibility to comply with the laws on drug safety and quality. Key requirements for drug manufacturing quality include the relevant provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA's Current Good Manufacturing Practice (CGMP) regulations. The FDA's CGMP requirements safeguard the safety of consumers and patients CGMP requirements are carefully designed, with multiple layers of processes, controls and quality oversight, to produce high-quality drugs and to detect and quickly mitigate potential problems before they cause harm to patients or consumers. When properly implemented, these requirements help ensure that drugs are safe, effective and compliant with regulatory standards. The FDA promotes drug manufacturers' compliance with CGMP requirements through inspections. The following information explains the actions the FDA takes to assess whether drug manufacturers meet CGMP requirements through CGMP inspections, and the measures it can take when these manufacturers fail to meet regulatory standards. How the FDA assesses and ensures compliance CGMP inspections For post-market inspections, the FDA uses a risk-based model each year to prioritize its surveillance inspections. The frequency with which a facility is prioritized for inspection is based on multiple risk factors (but being selected for inspection does not necessarily indicate a quality problem). In addition, if information supports it, the FDA may also inspect a facility for cause. Most manufacturers comply with CGMP requirements. In fact, more than 90% of inspections find that a facility's CGMP compliance is acceptable. When FDA investigators identify problems during an inspection, they use Form FDA 483 to record their observations related to CGMP compliance at the end of the inspection. Form FDA 483 does not constitute a final agency determination of whether any condition violates CGMP. Companies generally have 15 working days to voluntarily submit a response to Form FDA 483 to the FDA. The FDA's compliance review After an inspection, the FDA reviews the following information: any Form FDA 483 issued; the field inspection report written by the investigator; evidence collected during the inspection or through other agency activities; the company's response to Form FDA 483 (if submitted to the FDA), including its corrective action plan; other appropriate information. During the compliance review, the agency also considers: the requirements set out in FDA regulations; technical standards; scientific advice and literature from the agency's various offices; a profile of the manufacturing facility and the drugs it produces; a risk assessment of quality deviations, based on the risk of potential harm to patients or consumers. Inspection classification Based on a company's compliance status with CGMP requirements, the FDA classifies inspections as acceptable or unacceptable: A No Action Indicated (NAI) classification indicates that the facility is in an acceptable state of compliance. Generally, the facility does not receive a Form FDA 483 at the end of the inspection. A Voluntary Action Indicated (VAI) classification indicates that the inspection found objectionable conditions or practices, but the agency has decided that the facility can voluntarily correct its deficiencies and that no action will be recommended. Generally, the facility receives a Form FDA 483 at the end of the inspection. An Official Action Indicated (OAI) classification indicates that the facility is in an unacceptable state of compliance. The FDA strives to complete the CGMP classification of human-drug facility inspections within 90 days of the end of the inspection. The agency sends the facility a letter stating the classification (for example, NAI, VAI and OAI letters), and generally publishes the classification on a data dashboard.