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  2. Form FDA 483 - Wikipedia

    en.wikipedia.org/wiki/Form_FDA_483

    The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...

  3. First article inspection - Wikipedia

    en.wikipedia.org/wiki/First_article_inspection

    A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.

  4. Template:Infobox drug/doc/FDA-2023 - Wikipedia

    en.wikipedia.org/wiki/Template:Infobox_drug/doc/...

    * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).

  5. Hazard analysis and critical control points - Wikipedia

    en.wikipedia.org/wiki/Hazard_analysis_and...

    Hazard analysis and critical control points, or HACCP (/ ˈ h æ s ʌ p / [1]), is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level.

  6. Flow process chart - Wikipedia

    en.wikipedia.org/wiki/Flow_process_chart

    It is used when observing a physical process, to record actions as they happen, and thus get an accurate description of the process. It is used when analyzing the steps in a process, to help identify and eliminate waste—thus, it is a tool for efficiency planning. It is used when the process is mostly sequential, containing few decisions.

  7. Center for Food Safety and Applied Nutrition - Wikipedia

    en.wikipedia.org/wiki/Center_for_Food_Safety_and...

    The Center for Food Safety and Applied Nutrition (CFSAN (/ ˈ s ɪ f ˌ s æ n / SIF-san)) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.

  8. Process analytical technology - Wikipedia

    en.wikipedia.org/wiki/Process_analytical_technology

    The FDA has outlined a regulatory framework [1] for PAT implementation. With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the ...

  9. Process performance qualification protocol - Wikipedia

    en.wikipedia.org/wiki/Process_Performance...

    Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.