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    Equipment Qualification

    Uploaded by

    RainMan75
    Equipment qualification involves validating equipment used in pharmaceutical manufacturing through a series of qualification phases to ensure the equipment functions properly and produces products meeting specifications. The validation process begins with creating a user requirements specification document detailing the equipment's intended use and functions. This document forms the basis for design qualification, installation qualification, operational qualification, and performance qualification phases which work to establish the equipment is built, installed, and operates as intended to consistently manufacture quality products.

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    Equipment Qualification

    Uploaded by

    RainMan75
    235 views3 pages
    Equipment qualification involves validating equipment used in pharmaceutical manufacturing through a series of qualification phases to ensure the equipment functions properly and produces products meeting specifications. The validation process begins with creating a user requirements specification document detailing the equipment's intended use and functions. This document forms the basis for design qualification, installation qualification, operational qualification, and performance qualification phases which work to establish the equipment is built, installed, and operates as intended to consistently manufacture quality products.

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    Equipment Qualification

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    Equipment qualification involves validating equipment used in pharmaceutical manufacturing through a series of qualification phases to ensure the equipment functions properly and produces products meeting specifications. The validation process begins with creating a user requirements specification document detailing the equipment's intended use and functions. This document forms the basis for design qualification, installation qualification, operational qualification, and performance qualification phases which work to establish the equipment is built, installed, and operates as intended to consistently manufacture quality products.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    235 views3 pages

    Equipment Qualification

    Uploaded by

    RainMan75
    Equipment qualification involves validating equipment used in pharmaceutical manufacturing through a series of qualification phases to ensure the equipment functions properly and produces products meeting specifications. The validation process begins with creating a user requirements specification document detailing the equipment's intended use and functions. This document forms the basis for design qualification, installation qualification, operational qualification, and performance qualification phases which work to establish the equipment is built, installed, and operates as intended to consistently manufacture quality products.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    Equipment Qualification

    Contents

     Validation

     User Requirement Specification. (URS)

     Phase of validation

     Design qualification (DQ)

     Installation Qualification (IQ)

     Operation Qualification (OQ)

     Performance Qualification (PQ)

     Maintenance Qualification (MQ)

     Component Qualification (CQ)

    o Instrument Re-Qualification

    What is Validation
    According to the Food and Drug Administration (FDA), the goal of validation is to:
    “Establish documented evidence which provides a high degree of assurance that a
    specific process will consistently produce a product meeting its predetermined
    specifications and quality attributes.”
     It is a requirement for Good Manufacturing Practices and other regulatory
    requirements.

    What does this mean?


    A quantitative approach is needed to prove the quality, functionality, and
    performance of a pharmaceutical/biotechnological manufacturing process.

     This approach will be applied to individual pieces of equipment as well as the


    manufacturing process as a whole.

     Guidelines for validation are set by the FDA, but the specifications of validation
    are determined by the pharmaceutical/biotech company.

    User Requirements Specification (URS):


    User Requirements Specification (URS), is the most critical of documents and yet, the
    most often bungled. Whether the system is purely mechanical, or a mix of electro-
    mechanical, or solely a software program, the successful compilation and execution of
    the Installation Qualification (IQ) (for installation), Operational Qualification (OQ) (for
    functionality), and the Performance / Product Qualification (PQ) (for operability), is
    dependent on a User Requirements Specification (URS) containing clear, concise and
    testable requirements.

    Once the end user requirements specification is documented, agreed and approved they
    form the basic URS Level-1 document.
    The engineers (or vendor) can then commence the preliminary design to establish exactly
    what functions are required for each of
    the items specified in the user requirements specification, the end user has listed. Once
    this functionality is documented and
    approved it forms URS Level-2 document. This is the final level of the URS unless
    software is used.
    If software is to be used, the URS Level-2 document, is passed to the code writers. As the
    code is written, lines, or groups of lines,
    of code must be attributed to the individual functions that necessitate their presence. The
    completion of this task results in
    the completion of the URS Level-3 document

    Developing the URS to this level is unique in most industries, but is, standard practice in
    strictly regulated industries, as it is a
    major building block in the creation of quality software. The URS Level-3 document,
    contains all the traceability which is deemed
    mandatory for software assessed to be critical to product quality, in the pharmaceutical
    regulated industries.
    The URS can contain a large number of requirements and should therefore be structured
    in a way that will permit easy access to information.
    The requirement specification must be formally reviewed and approved by the
    pharmaceutical manufacturer.
    The following guidelines should be followed during the production of the URS :
    1. Each requirement statement to be uniquely referenced, and no longer than 250
    words.

    2. Requirement statements should not be duplicated or contradicted.

    3. The URS should express requirements and not design solutions.

    4. Each requirement should be testable.

    5. The URS must be understood by both user and supplier, ambiguity and jargon
    should be avoided.

    6. The use of diagrams is often useful.

    7. The scope for readers to make assumptions or misinterpret

    8. Should be minimized.

    9. Wherever possible, the URS should distinguish between mandatory/regulatory


    requirements and desirable features.

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