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    Review and Release of Results From The Analytical Laboratory Notebooks

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    Haroon Ahsan
    This two-page standard operating procedure provides a checklist for reviewing analytical laboratory notebooks and releasing test results. The checklist contains 12 items to verify for the notebook, including the analytical method used, sample information, test conduct according to the method, standards, results, and interrupted work. It also has sections to check the raw data for compatibility and conformity. The final section ensures equipment was calibrated and dissolution bath performance was checked. The purpose is to ensure test results in the notebooks are accurate and conducted properly according to the analytical method before being released.

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

    Review and Release of Results From The Analytical Laboratory Notebooks

    Uploaded by

    Haroon Ahsan
    43 views2 pages
    This two-page standard operating procedure provides a checklist for reviewing analytical laboratory notebooks and releasing test results. The checklist contains 12 items to verify for the notebook, including the analytical method used, sample information, test conduct according to the method, standards, results, and interrupted work. It also has sections to check the raw data for compatibility and conformity. The final section ensures equipment was calibrated and dissolution bath performance was checked. The purpose is to ensure test results in the notebooks are accurate and conducted properly according to the analytical method before being released.

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    Steps of Procedures

    Original Title

    Sop

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    This two-page standard operating procedure provides a checklist for reviewing analytical laboratory notebooks and releasing test results. The checklist contains 12 items to verify for the notebook, including the analytical method used, sample information, test conduct according to the method, standards, results, and interrupted work. It also has sections to check the raw data for compatibility and conformity. The final section ensures equipment was calibrated and dissolution bath performance was checked. The purpose is to ensure test results in the notebooks are accurate and conducted properly according to the analytical method before being released.

    Copyright:

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

    Review and Release of Results From The Analytical Laboratory Notebooks

    Uploaded by

    Haroon Ahsan
    This two-page standard operating procedure provides a checklist for reviewing analytical laboratory notebooks and releasing test results. The checklist contains 12 items to verify for the notebook, including the analytical method used, sample information, test conduct according to the method, standards, results, and interrupted work. It also has sections to check the raw data for compatibility and conformity. The final section ensures equipment was calibrated and dissolution bath performance was checked. The purpose is to ensure test results in the notebooks are accurate and conducted properly according to the analytical method before being released.

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    You are on page 1of 2

    SOP # A-060-02-010Y

    STANDARD OPERATING
    PROCEDURES

    Page: 1 of 2.

    Review and Release of Results from the Analytical Laboratory Notebooks.


    REVIEWER CHECKLIST - LAB NOTEBOOK
    NOTEBOOK

    YES

    NO

    1. Analytical Method:
    Test
    Test Number
    Edition #:
    Same as the one used for testing
    Date of Edition
    2. Full and correct name of sample tested
    3. Description of operating conductors according to the analytical method.
    4. Compatibility of actual work with the analytical method.
    5. Inserts of Weights (date, number of notebook, pH, titration results, name
    of analyst), spectra graphs and chromatograms.
    6. Standards:
    Assay
    Water content
    RLB
    Specifications as in valid Certificate of Analysis
    Use before retest date
    7. Standard Solutions:
    Repeatability of injections
    Repeatability of control injections
    Used within time permitted
    8. Results:
    Difference between duplicates
    Questionable result and OOS
    Repeated significant figures
    9. System Suitability Graphs:
    Compatible with method
    Compliance with method (tailing factor, resolution, no. of theoretical
    plates)
    Appropriate concentrations
    Appropriate running conditions (time of run, RRT)
    10.Interrupted Work:
    Reason noted
    Signature
    11.Retest:
    According to SOP (investigation, etc.)
    12.Erasure of the test - signature and date

    ED. N0:
    NEW
    Ed. Status :
    ORIGINAL

    Effective Date:

    APPROVED:

    http://www.iagim.org

    DD / MM / 200Y

    Laboratory
    Handbook of Pharmaceutical Generic Development

    QC
    QA
    info@locumUSA.com

    HEAD
    24 Volume Series

    SOP # A-060-02-010Y

    STANDARD OPERATING
    PROCEDURES

    Page: 2 of 2.

    Review and Release of Results from the Analytical Laboratory Notebooks.


    REVIEWER CHECKLIST - LAB NOTEBOOK
    YES

    RAW DATA

    NO

    Name of sample
    Dates compatible and in chronological order with dates in notebooks,
    raw data and documents
    Conformity of successive graphs
    Running time and RRTs according to method and edition
    Canceled Chromatograms and spectra with signed explanation
    Graph of system suitability compatible with method
    Discrepancies between original date (area responses, absorbance
    values) and those reported in notebook, computer sheets and
    documents.
    Extraneous peaks in standard and sample solutions:
    Number of peaks found
    Size of peaks (less or more than QL)

    YES

    EQUIPMENT

    NO

    - Calibrated at the time of use


    - Performance check of dissolution bath

    ED. N0:
    NEW
    Ed. Status :
    ORIGINAL

    Effective Date:

    APPROVED:

    http://www.iagim.org

    DD / MM / 200Y

    Laboratory
    Handbook of Pharmaceutical Generic Development

    QC
    QA
    info@locumUSA.com

    HEAD
    24 Volume Series

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