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  • Sop For Analytical Method Validation

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    Dolly Bijani
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    This document outlines procedures for validating analytical methods used by an organization. It defines method validation as ensuring results are accurate and reliable by meeting acceptance criteria. It assigns responsibilities for coordinating, reviewing, and archiving validation. The procedure specifies developing a protocol before validation, executing the validation, analyzing data, preparing a report, obtaining approvals, and archiving records in compliance with the organization's policies.

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    SOP FOR ANALYTICAL METHOD VALIDATION

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    This document outlines procedures for validating analytical methods used by an organization. It defines method validation as ensuring results are accurate and reliable by meeting acceptance criteria. It assigns responsibilities for coordinating, reviewing, and archiving validation. The procedure specifies developing a protocol before validation, executing the validation, analyzing data, preparing a report, obtaining approvals, and archiving records in compliance with the organization's policies.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    503 views3 pages

    Sop For Analytical Method Validation

    Uploaded by

    Dolly Bijani
    This document outlines procedures for validating analytical methods used by an organization. It defines method validation as ensuring results are accurate and reliable by meeting acceptance criteria. It assigns responsibilities for coordinating, reviewing, and archiving validation. The procedure specifies developing a protocol before validation, executing the validation, analyzing data, preparing a report, obtaining approvals, and archiving records in compliance with the organization's policies.

    Copyright:

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

    Standard Operating Procedure (SOP) for Analytical Method Validation

    SOP Number: [Unique SOP Number]

    Effective Date: [Effective Date]

    Review Date: [Review Date]

    Approval Signatures:

    Name Title Date

    [Name of Approver 1] [Title of Approver 1] [Approval Date]

    [Name of Approver 2] [Title of Approver 2] [Approval Date]

    1. Purpose:

    The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for the
    validation of analytical methods used in [Your Organization's Name]. Method validation ensures that
    analytical results are accurate, reliable, and meet predetermined acceptance criteria.

    2. Scope:

    This SOP applies to all personnel involved in the validation of analytical methods within [Your
    Organization's Name]. It covers the validation of both new and existing analytical methods.

    3. Responsibilities:

    3.1. [Specify Department/Role] is responsible for coordinating and conducting analytical method
    validation.

    3.2. [Specify Department/Role] is responsible for reviewing and approving method validation
    protocols and reports.
    3.3. [Specify Department/Role] is responsible for archiving and maintaining method validation
    records.

    4. Definitions:

    Analytical Method: The specific procedure used for the quantitative or qualitative determination of
    an analyte in a sample.

    Validation: The process of demonstrating that an analytical method is suitable for its intended
    purpose and provides reliable results.

    5. Procedure:

    5.1. Method Selection:

    The selection of an appropriate analytical method should consider factors such as the intended use,
    regulatory requirements, and the analyte's characteristics.

    5.2. Method Validation Protocol:

    Prior to validation, a validation protocol must be prepared. The protocol should include:

    A unique document number and version.

    Objective and scope.

    Reference to relevant SOPs.

    Detailed experimental procedures.

    Acceptance criteria.

    Statistical methods (if applicable).

    A timeline for completion.

    5.3. Method Validation Execution:

    Execute the validation protocol as per the documented procedures.

    Ensure trained personnel perform the validation.

    Record all relevant data and observations during the validation process.

    5.4. Data Analysis:


    Analyze the validation data, including statistical analysis (if applicable), to determine if the method
    meets the predefined acceptance criteria.

    5.5. Validation Report:

    Prepare a validation report that summarizes the results, conclusions, and any recommendations.

    Include references to the validation protocol, experimental data, and any deviations encountered.

    5.6. Review and Approval:

    The validation report must be reviewed and approved by [Specify Department/Role] and [Specify
    Department/Role] before finalization.

    5.7. Archiving:

    All method validation records, including protocols and reports, must be archived and retained in
    accordance with [Your Organization's Name]'s document retention policy.

    6. References:

    List any relevant standards, guidelines, or regulatory documents that apply to analytical method
    validation.

    7. Attachments:

    Include any necessary attachments, such as forms, templates, or additional documents related to
    method validation.

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