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    Standard Operating Procedures "Sops": Pharmacist University of The Punjab-Pakistan

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    Muhammad Bilal Tahir
    The document discusses standard operating procedures (SOPs) for clinical research. It defines SOPs as detailed written instructions to ensure uniform performance of specific functions. SOPs describe tasks, assign responsibilities, train staff, and monitor performance. While not explicitly required by law, SOPs are implied by FDA regulations and emphasized in ICH GCP guidelines. The document provides tips for writing, implementing, and monitoring effective SOPs.

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    Standard Operating Procedures "Sops": Pharmacist University of The Punjab-Pakistan

    Uploaded by

    Muhammad Bilal Tahir
    192 views16 pages
    The document discusses standard operating procedures (SOPs) for clinical research. It defines SOPs as detailed written instructions to ensure uniform performance of specific functions. SOPs describe tasks, assign responsibilities, train staff, and monitor performance. While not explicitly required by law, SOPs are implied by FDA regulations and emphasized in ICH GCP guidelines. The document provides tips for writing, implementing, and monitoring effective SOPs.

    Original Description:

    sop lecture

    Original Title

    SOP_Bilal

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    The document discusses standard operating procedures (SOPs) for clinical research. It defines SOPs as detailed written instructions to ensure uniform performance of specific functions. SOPs describe tasks, assign responsibilities, train staff, and monitor performance. While not explicitly required by law, SOPs are implied by FDA regulations and emphasized in ICH GCP guidelines. The document provides tips for writing, implementing, and monitoring effective SOPs.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    192 views16 pages

    Standard Operating Procedures "Sops": Pharmacist University of The Punjab-Pakistan

    Uploaded by

    Muhammad Bilal Tahir
    The document discusses standard operating procedures (SOPs) for clinical research. It defines SOPs as detailed written instructions to ensure uniform performance of specific functions. SOPs describe tasks, assign responsibilities, train staff, and monitor performance. While not explicitly required by law, SOPs are implied by FDA regulations and emphasized in ICH GCP guidelines. The document provides tips for writing, implementing, and monitoring effective SOPs.

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    Standard Operating Procedures

    SOPs
    Bilal Tahir
    Pharmacist
    Doctor of Pharmacy, M.Phil (Pharmaceutics)
    University of the Punjab-Pakistan
    What are SOPs?
    International Conference on
    Harmonization (ICH) defines a SOP as
    Detailed, written instructions to
    achieve uniformity of the
    performance of a specific function.
    (ICH GCP 1.55)
    What are SOPs?
    In simple terms a SOP is
    A written process
    A way to perform a task in the same
    way each time it is completed.
    SOPs are used to:
    Identify the responsible person for each
    task.
    Describe actions (what is to be
    completed).
    Train staff.
    Monitor site performance.
    Are SOPs Required by
    Law/Regulations?
    SOPs are not specifically mentioned in the
    FDA regulations

    HOWEVER there is guidance and regulations


    that infer responsibility and SOPs formalize
    investigator responsibilities.

    the investigator will ensure that all


    associates, colleagues, and employees
    assisting in the conduct of the study (ies) are
    informed of their obligations in meeting the
    above commitments.
    Additionally, SOPs are mentioned repeatedly
    in the ICH GCP Guidelines.

    According to ICH GCP -Systems with


    procedures that assure the quality of every
    aspect of the trial should be implemented.
    An SOP is a procedure specific to your operation that
    describes the activities necessary to complete tasks
    in accordance with industry regulations, provincial
    laws or even just your own standards for running
    your business. Any document that is a how to falls
    into the category of procedures. In a manufacturing
    environment, the most obvious example of an SOP is
    the step by step production line procedures used to
    make products as well train staff.
    An SOP, in fact, defines expected practices in
    all businesses where quality standards exist.
    SOPs play an important role in your small
    business. SOPs are policies, procedures and
    standards you need in the operations,
    marketing and administration disciplines
    within your business to ensure success.
    Writing SOPs
    Develop a template for the SOP to be used
    throughout the document.
    Potential elements of the SOP
    Header title, original version date, revision date, effective
    date, approved by
    Purpose why one has the policy
    Responsibilities who the policy pertains to
    Instruction/Procedures how to accomplish the items of
    the policy
    References what the policy is based on
    Appendix source documents/case report forms
    Flow Chart For SOP
    Woodin, K. (2004) The CRCs Guide to Coordinating Clinical Research p. 60-65. Centerwatch

    Primary Step
    Ensure Add the Add the Turn on Serve the
    the coffee coffee water the coffee
    maker is machine
    ready
    Secondary Step

    Ensure Add the Add the Turn on Serve the


    the coffee coffee water the coffee
    maker is machine
    ready

    Ensure the Place a Use the Wait until


    machine is filter in carafe to the coffee
    plugged in the basket measure has
    the water stopped
    dripping

    Place the
    Ensure Measure
    carafe /
    carafe / the coffee
    flask on
    flask is
    the
    empty and
    heating
    clean
    element
    Tips for Writing SOPs

    Use clear, concise language.

    Use active voice.

    Avoid names; use titles instead.


    Implementing and Monitoring SOPs

    SOPs should be introduced gradually.

    Prioritize most relevant SOPs and


    present them first.

    Principle Investigator should approve


    all SOPs and designate an effective
    date.
    Implementing and Monitoring SOPs

    SOPs should be reviewed on a


    regular basis (usually annually) to
    ensure policy based regulations are
    up-to-date.

    Previous versions of SOPs should be


    retained.
    Reference
    Examples from National Cancer Institute
    https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practice
    s/SOPs/SOPs

    Standard Operating Procedures for Good Clinical Practice at the


    Investigative / Centerwatch
    http://www.ccrp.com/sop.shtml
    Cost $995 for single site license

    Standard Operating Procedures (SOPs) for Good Clinical Practice /


    University of Washington
    http://www.crc.washington.edu/Resources/GCPSOPInvSites.aspx
    Cost $135

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