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  1. #1
    Validation Analyst
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    Apr 2009
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    Default SOP vs. WI- difference?

    What is the difference between an SOP (Standard Operating Procedure) and a WI (Work Instruction)?

    There is a lot of confusion in my company reagarding this distinction. We are a bio-tech company that makes hardware and software products that are sold to both R&D and GMP labs. I have been pushing the development of more procedures to govern our activities, but I am not clear on when a procedure should be classified as an SOP vs. WI.

    Thanks!

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  3. #2
    Validation Expert
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    Mar 2008
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    SOP is higher level of documentation than WI. That is most important difference by my opinion.
    And, don't be in confusion everything in pharmacy is a little bit in confusion

    rgds,

    cubica

  4. #3
    Validation Guru
    Join Date
    Oct 2007
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    343

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    To me, it's simply "what" -v- "how." SOPs tell you what to do; e.g., calibration. If it's necessary that the 'what' be done exactly the same way each time, then you write a WI on how to do it; e.g., to calibrate a balance you... Your SOPs should cover all your regulatory requirements.

    Why do you feel you need more procedures? More procedures does not imply more control. Maybe flowchart your process first and get agreement on that. Then, look for areas that could, if done inconsistently or incorrectly, (or are currently being done inconsistently and incorrectly) lead to quality problems. Then, you may have a justifiable case (not just a feel) for adding procedures.

  5. #4
    Validation Guru
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    Sep 2007
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    London
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    Quote Originally Posted by tiffjoy View Post
    What is the difference between an SOP (Standard Operating Procedure) and a WI (Work Instruction)?

    There is a lot of confusion in my company reagarding this distinction. We are a bio-tech company that makes hardware and software products that are sold to both R&D and GMP labs. I have been pushing the development of more procedures to govern our activities, but I am not clear on when a procedure should be classified as an SOP vs. WI.

    Thanks!
    Basically in QMS term procedure has been used, but infact work instruction is not a wrong word, to me it can be a sub part of an SOP. A work instruction would be used where some further detail is required to describe an activity which is related to the procedure. A work instruction as the name indicates is typically focused on step by step elaborated instructions while SOP is all about defined system and overall process.
    Dr. Shahid A Syed
    QA/Validation Specialist
    Penn Pharmaceutical
    www.pennpharm.com

  6. #5
    Validation Analyst
    Join Date
    Apr 2009
    Posts
    4

    Default

    Thanks for the replies. It's definitely clearer now.

    The reason I was pushing for more procedures was because we have a couple groups who perform very involved activities, but they do not have even one SOP or WI for anything. And it's been having a negative impact on me because when someone new comes in, there are no procedures, so they mess up everything. I then get to deal with the fallout.

    Thanks for the clarification!

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