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    11 - Standard Operating Procedures

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    reddyrani928

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    11 - Standard Operating Procedures

    Uploaded by

    reddyrani928
    5 views12 pages

    Original Title

    11- Standard Operating Procedures

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    Copyright:

    © All Rights Reserved
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    Download as pdf or txt
    5 views12 pages

    11 - Standard Operating Procedures

    Uploaded by

    reddyrani928

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 12

    Standard Operating Procedures

    SOP
    Goals and Objectives

    Define what is an SOP

    Purpose of Having SOPs

    Describe how to write an SOP


    What Is SOP

     Standard operating procedures are a set of


    instructions having the force of a directive, covering
    those features of operations that lend themselves to a
    definite or standardized procedure without loss of
    effectiveness.
     They addresses all requirements to perform
    laboratory procedures safely.
     SOPs will fail if they are not followed, therefore, the
    use of SOPs needs to be reviewed and re-enforced by
    management.
    What Is SOP

     An SOP is a set of written instructions that document


    a routine or repetitive activity.
    What Is SOP

     SOPs: Detailed written instructions to achieve


    uniformity of the performance of a specific function.
    Purpose of Having SOP’s

    To provide people with all the information necessary


    to perform a job properly (i.e. a training tool)

    To ensure that the procedures are performed correctly


    and consistently

    To ensure compliance with government regulations


    Purpose of Having SOP’s

     SOPs detail the regularly recurring work processes


    that are to be conducted or followed within an
    organization.

     They document the way activities are to be performed


    to maintain consistency with technical operations and
    to support data quality.
    .
     SOP’s maintain quality control and quality assurance
    processes and ensure compliance with governmental
    regulations.
     SOPs are usually specific to the organization or facility
    How to Write SOPs

     Cover the necessary material. In general, technical


    SOPs will consist of four elements apart from the
    procedure itself:

     Title page. This includes


    1) the title of the procedure,
    2) an SOP identification number
    3) date of issue or revision
    4) the name of the agency/division/branch the SOP applies
    to
    5) the signatures of those who prepared and approved of the
    SOP.
    This can be formatted however you like, as long as the
    information is clear.
    How to Write SOPs

     Table of Contents. This is only necessary if your


    SOP is quite long, allowing for ease of reference. A
    simple standard outline is what you'd find here.

     Reference. Be sure to list all cited or significant


    references. If you reference other SOPs, be sure to
    attach the necessary information in the appendix.
    How to Write SOPs

     Scope and applicability. In other words, describe the purpose of


    the process, its limits, and how it's used. Include standards,
    regulatory requirements, roles and responsibilities, and inputs and
    outputs.
     Methodology and procedures. The meat of the issue -- list all
    the steps with necessary details, including what equipment needed.
    Cover sequential procedures and decision factors. Address the
    "what ifs" and the possible interferences or safety considerations.
     Clarification of terminology. Identify acronyms, abbreviations,
    and all phrases that aren't in common parlance.
     Health and safety warnings. To be listed in its own
    section and alongside the steps where it is an issue. Do not gloss
    over this section.
     Equipment and supplies. Complete list of what is needed and
    when, where to find equipment, standards of equipment, etc.
    SOPs for Clinical Trial Laboratory

     SOPs for Clinical Trial Lab Should cover:


     Process How A query will be addressed
     Research over a project
     Submission of Proposal
     Introduction of Study Team
     Preparation of Documents Formats
     Approval of document formats
     Supplies to Investigator sites
     Dummy Run
     Specimen Collection
     Registration of Samples
     Reporting of Lab Results
     Audit
     Specimen Storage
     Data Transfer
    SOPS for Clinical Trials

    QUESTIONS?

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