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    SOP Productrecall

    Uploaded by

    Eyob Mola
    This standard operating procedure outlines the process for product recalls initiated by Panorama in Nova Scotia. It details the roles and responsibilities of the provincial biological depot, zone biological coordinators, and public health staff. When the biological depot receives notification of a recall, the immunization coordinator confirms details and notifies zone coordinators by email. Zone coordinators then locate the recalled products, return them to the depot, and communicate the recall to local providers. The biological depot removes recalled products and stores them until returning them to the supplier.

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

    SOP Productrecall

    Uploaded by

    Eyob Mola
    28 views5 pages
    This standard operating procedure outlines the process for product recalls initiated by Panorama in Nova Scotia. It details the roles and responsibilities of the provincial biological depot, zone biological coordinators, and public health staff. When the biological depot receives notification of a recall, the immunization coordinator confirms details and notifies zone coordinators by email. Zone coordinators then locate the recalled products, return them to the depot, and communicate the recall to local providers. The biological depot removes recalled products and stores them until returning them to the supplier.

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    Soo for product recall

    Original Title

    SOP productrecall

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    This standard operating procedure outlines the process for product recalls initiated by Panorama in Nova Scotia. It details the roles and responsibilities of the provincial biological depot, zone biological coordinators, and public health staff. When the biological depot receives notification of a recall, the immunization coordinator confirms details and notifies zone coordinators by email. Zone coordinators then locate the recalled products, return them to the depot, and communicate the recall to local providers. The biological depot removes recalled products and stores them until returning them to the supplier.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    28 views5 pages

    SOP Productrecall

    Uploaded by

    Eyob Mola
    This standard operating procedure outlines the process for product recalls initiated by Panorama in Nova Scotia. It details the roles and responsibilities of the provincial biological depot, zone biological coordinators, and public health staff. When the biological depot receives notification of a recall, the immunization coordinator confirms details and notifies zone coordinators by email. Zone coordinators then locate the recalled products, return them to the depot, and communicate the recall to local providers. The biological depot removes recalled products and stores them until returning them to the supplier.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    A

    SOP#:
    Page

    STANDARD OPERATING PROCEDURE

    Chapter: Science System and Performance SOP#:


    (SSP)
    Section: Vaccine Storage and Handling
    Subject: NSHA: Product Recalls (Panorama)
    Approved by: Approval Date:
    Applies To: Public Health Staff

    INTRODUCTION

    Successful immunization programs are dependent upon proper handling and


    storage of biological products. Careful management of vaccine product recalls
    are critical as the manufacturer has determined that the product is potentially
    unsafe for the public.

    The purpose of this standard operating procedure is to outline the process for
    product recalls, initiated by Panorama. Only the Inventory Provincial role has
    permissions for the Create Product recall functionality in Panorama.

    Product Recall

    Provincial Biological Depot Pharmacy Practicing Assistant

    1. The Biological Depot receives notification that product has been recalled.

    2. The Biological Depot Pharmacy Practicing Assistant will select Process


    product recall in the Inventory Maintenance menu and create a product recall
    in Panorama (hyperlink to user guide sheet).

    Provincial Biological Depot Immunization Coordinator

    3. The Provincial Biological Depot Immunization Coordinator confirms the


    product recall from the manufacturer, specifically, date of notification, brand
    name, product description, lot #, expiry date, reason/problem for recall and
    company.

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    4. The Provincial Biological Depot Immunization Coordinator communicates the


    product recall to the DHW CDPC Consultant by email and initiates product
    recall from the Bio-depot and Zone Public Health.

    5. The Provincial Biological Depot Immunization Coordinator communicates


    (email) the immediate product recall to all the Zone Bio-coordinators,
    including Zone Health Protection Managers (Appendix 1).

    Zone Biological Coordinators

    6. The Zone Biological Coordinators will search and view the product recall in
    Panorama (hyperlink to user guide sheet).

    7. The Zone Biological Coordinators will contact all holding point locations
    where the recalled products are located (hyperlink to user guide sheet).

    8. The Zone Biological Coordinators will search for recall product active
    requisitions and the status of these requisition (hyperlink to user guide
    sheet).

    9. The Zone Biological Coordinators pull all product identified in the product
    recall from their bio-depot to be returned to the Provincial Bio-depot.

    10. The Zone Biological Coordinators communicate with service providers,


    transit points to return all product identified in the product recall.

    11. The Zone Biological Coordinators receive returns from zone providers in
    Panorama (SOP Receiving Returns).

    12. The Zone Biological Coordinator returns product to the Provincial Bio-
    depot (SOP Receiving Returns).

    Provincial Biological Depot Pharmacy Practicing Assistant

    13. The Biological Depot Pharmacy Practicing Assistant removes all product
    identified in the product recall from the Provincial Bio-depot.

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    14. The Biological Depot Pharmacy Practicing Assistant receives products


    from the Zone Bio-coordinators (SOP Receiving Returns).

    15. Vaccines are stored until SOP Vaccine Return to Supplier is initiated by
    the Bio-depot Pharmacy Practicing Assistant (SOP Return to Supplier).

    DEFINITIONS

    Biologicals The vaccine storage facility located within Public Health


    Depot (PH) housing vaccines for district and provincial
    distribution.

    REFERENCES

    Nova Scotia Department of Health and Wellness. (2017). Nova Scotia


    immunization manual. Retrieved from
    http://novascotia.ca/dhw/cdpc/documents/Immunization-
    Manual.pdf

    Public Health Agency of Canada (2015). National Vaccine Storage and Handling
    Guidelines for Immunization Providers 2015. PHAC, Ottawa, ON.

    Government of Canada Recalls and Alerts (2017)


    http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/search-
    recherche/simple?s=&plain_text=&f_mc=3&js_en=&page=5&f_mc=3&f_sc=73

    USA Food and Drug Administration (2017). Guidance for Industry: Product
    recalls, Including Removals and Corrections (2017). USA Food and Drug
    Administration located at
    https://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm

    HISTORY

    CURRENT VERSION
    Prepared by: Stacey Dunphy

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    SOP#:
    Page

    16. Reviewed by: Version Jana Vickers

    17. #: October 13 , 2017

    RESCINDED VERSIONS
    SOP #:
    Version #:
    SOP Subject:
    Approved by:
    Date approved:

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    Appendix 1 - Provincial Biological Depot

    URGENT MEMORANDUM

    To: Health Protection Managers, Public Health/ Manager, Health Protection, Scientific & System
    Performance, Public Health / Biological Clerk Coordinators

    From: Immunization Coordinator Provincial Biological Depot

    Date:

    RE: NS Biological Depot Product Recall

    Background:

    Specific details regarding product recall using the format of Canada,gc.ca Product
    Recalls and Alerts Biologic Vaccine @ http://www.healthycanadians.gc.ca/recall-
    alert-rappel-avis/search-
    recherche/simple?s=&plain_text=&f_mc=3&js_en=&page=5&f_mc=3&f_sc=73
    Product Recall

    Date Brand Name Product Reason/Problem Company


    Notification Description (lot
    number/expiration
    date)

    Return Process to the Provincial Bio-depot

    1) Communication with Service Providers to return product to Zone Bio-depot.


    2) Zone Bio-depot Coordinator returns product to Provincial Biological Depot.

    Questions regarding product recall can be sent to the Immunization Coordinator.

    Respectfully,

    Nova Scotia Biological Depot Immunization Coordinator

    Contact Information
    5

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