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    What Is 21 CFR Part 820

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    umeshchandra24276
    21 CFR Part 820 establishes current good manufacturing practice (CGMP) requirements for medical device companies to ensure they deliver safe, effective, and compliant products. It requires companies to establish a quality management system and addresses topics like design controls, design transfer, design changes, process and design validation, and verification.

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    What Is 21 CFR Part 820

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    umeshchandra24276
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    21 CFR Part 820 establishes current good manufacturing practice (CGMP) requirements for medical device companies to ensure they deliver safe, effective, and compliant products. It requires companies to establish a quality management system and addresses topics like design controls, design transfer, design changes, process and design validation, and verification.

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    WHAT IS 21 CFR PART 820

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    21 CFR Part 820 establishes current good manufacturing practice (CGMP) requirements for medical device companies to ensure they deliver safe, effective, and compliant products. It requires companies to establish a quality management system and addresses topics like design controls, design transfer, design changes, process and design validation, and verification.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    10 views2 pages

    What Is 21 CFR Part 820

    Uploaded by

    umeshchandra24276
    21 CFR Part 820 establishes current good manufacturing practice (CGMP) requirements for medical device companies to ensure they deliver safe, effective, and compliant products. It requires companies to establish a quality management system and addresses topics like design controls, design transfer, design changes, process and design validation, and verification.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    WHAT IS 21 CFR PART 820?

    21 CFR Part 820 is a set of regulations from FDA that offers current good manufacturing practice
    (CGMP) requirements. These CGMP requirements ensure medical device companies establish a QMS
    that enables them to deliver safe, effective, and compliant products

    “the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished
    devices intended for human use,” including the facilities and designs used for those processes

    . It consists of 15 subparts

    Validation means confirmation by

    examination and provision of objective

    evidence that the particular requirements for a specific intended use can

    be consistently fulfilled.

    (1) Process validation means establishing by objective evidence that a

    process consistently produces a result

    or product meeting its predetermined

    specifications.

    (2) Design validation means establishing by objective evidence that device specifications conform
    with user

    needs and intended use(s).

    Verification means confirmation by examination and provision of objective evidence that specified
    requirements have been fulfilled

    Validation means confirmation by examination and provision of objective evidence that the
    particular requirements for a specific intended use can be consistently fulfilled.

    Verification:

    Purpose: Verification checks if you built the product right (measuring against specifications).

    When: It happens during the design and development phase.

    Activities: It involves testing and checking to meet design specifications.

    Outcome: It confirms the product matches its design on paper.


    Validation:

    Purpose: Validation checks if you built the right product (meeting user needs).

    When: It occurs after the product is made and used in real-life situations.

    Activities: It involves real-world testing to ensure the product works as intended for users.

    Outcome: It confirms the product meets user expectations and works effectively in its intended
    environment.

    Design controls.

    establish and maintain procedures to control the design of the device in order to ensure that
    specified design requirements are met.

    Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device
    design is correctly translated into production specifications

    Design changes. Each manufacturer shall establish and maintain procedures for the identification,
    documentation, validation or where appropriate verification, review, and approval of design changes
    before their implementation

    1. DHF (Device History File): The Device History File is a comprehensive record that
    contains all the documented information related to the design, manufacturing, and
    quality of a medical device. It includes design inputs, verification and validation records,
    manufacturing processes, inspection results, and other essential data. The DHF serves as a
    historical reference for the entire lifecycle of the device and is a key document during
    regulatory audits.
    2. DHR (Device History Record): The Device History Record is a collection of documents
    and records specific to the production of an individual batch or unit of a medical device.
    It includes details about the manufacturing processes, quality control checks, test results,
    and any deviations or non-conformances encountered during production. The DHR is
    created for each device to provide a traceable history of its manufacturing.
    3. DMR (Device Master Record): The Device Master Record is a compilation of all the
    documents and specifications necessary for the consistent and accurate production of a
    medical device. It includes information such as design specifications, production
    processes, quality control procedures, labeling requirements, and any other relevant
    details. The DMR serves as a reference for ensuring that each device produced adheres to
    the approved design and quality standards.

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