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  2. Good manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_manufacturing_practice

    Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]

  3. Good automated manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_Automated...

    The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2] Other publications in the GAMP series include: GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems

  4. GxP - Wikipedia

    en.wikipedia.org/wiki/GxP

    GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.

  5. Quality management system - Wikipedia

    en.wikipedia.org/wiki/Quality_management_system

    The software makes closed-loop corrective and preventive action procedures (CAPA) possible, which result in faster issue resolution and issue prevention. Feedback loops: Quality management software permits staff to submit feedback or recommendations through centralized software. In turn, this way, managers gather insights from the shop floor ...

  6. Clinical quality management system - Wikipedia

    en.wikipedia.org/wiki/Clinical_Quality...

    Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...

  7. Pharmaceutical distribution - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_distribution

    In the US, Good Manufacturing Practice (GMP) Regulations are based on the Code of Federal Regulations 21 CFR 210/211, and USP 1079. The US Drug Supply and Chain Security Act (DSCSA), was enacted by Congress on November 26, 2013 and outlines requirements to build electronic systems that identify and trace prescription drugs distributed in the US ...

  8. Laboratory information management system - Wikipedia

    en.wikipedia.org/wiki/Laboratory_information...

    A LIMS covers standards such as 21 CFR Part 11 from the Food and Drug Administration (United States), ISO/IEC 17025, ISO 15189, ISO 20387, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), FDA Food Safety Modernization Act (FSMA), HACCP, and ISBER Best Practices.

  9. Validation master plan - Wikipedia

    en.wikipedia.org/wiki/Validation_master_plan

    It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation projects. [2] Food and Drug Administration inspectors often look at VMPs during audits to see whether or not a facility's validation strategy is well thought-out and organized.

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