Regulatory Open Forum

 View Only
  • 1.  Change History of SOPs

    Posted 26-Jan-2012 07:53
    My question relates to maintaining change history of SOPs. We are looking at two options and need expert opinion as to which one is acceptable/not acceptable and why.

    1. Change history will be listed like:
    Section 3: Responsibilities elaborated
    Section 4: Step 4.3 added
    Section 5: Step 5.5 deleted

    2. Track all changes in MS Word document and keep this Word document with all changes tracked as record of changes and no list is to generated of the changes made.

    Thank you for your insight.

    Yours,
    Wajeeh Bajwa


    --------------------------------------------------------
    Wajeeh Bajwa
    Director Regulatory Knowledge and Research Support Program
    University of Florida
    Gainesville FL
    United States
    -------------------------------------------


  • 2.  RE:Change History of SOPs

    Posted 26-Jan-2012 14:07
    I think you want to consider this from more than one point of view.
    One issue is the question of training users on the procedure changes.  The first approach that you describe seems to me the most useful for users because it allows them to zero in on what they need to know is different from what they have been doing.  This is the kind of information that I think users need to find somewhere in the document that they will be using.
    The other side is the record of the change in case a regulatory agency is asking exactly what was in place when.  I believe that the second option is something that should be available in the documentation center stored in a way that allows ready access in case of a regulatory audit.  I would be uncomfortable facing an auditor without knowing that this information is available to me.

    -------------------------------------------
    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
    -------------------------------------------








  • 3.  RE:Change History of SOPs

    Posted 26-Jan-2012 17:47
    Considering that INDs are specific to an indication and that CMC supports the information relative to the clinical trial material, an IND amendment is appropriate.  Even if it is a biologic or small molecule any changes to processes would go under the original IND.  If another indication uses the same clinical trial material then you have the option to cross reference the IND where the original CMC information was submited or submit the CMC information the new IND for a new indication.  One approach is more work and the other is less work. 

    Hope this helps!

    -------------------------------------------
    Darlene Rosario
    VP Research Program Management, Oncology
    MannKind Corporation
    Valencia CA
    United States
    -------------------------------------------








  • 4.  RE:Change History of SOPs

    Posted 27-Jan-2012 09:58
    One aspect you have to consider is the training on the new SOP and thus you would want anybody to know and have ready access to significant changes.  I use a combination of both methods and have in the SOP revision a short section (Change History) of major or significant changes then in the QMS folder retain the redline changes that might have the major changes as well as typos, line number changes, changes in signatory, etc. 

    -------------------------------------------
    John McLane
    COO & VP Clinical and Regulatory
    Clinquest, Inc.
    Hudson MA
    United States
    -------------------------------------------








  • 5.  RE:Change History of SOPs

    Posted 06-Feb-2012 13:34
    Wajeeh,

    As the former Manager of Documentation and Training for Wyeth (now Pfizer), I would like you to consider the following. If you are asked to provide an auditor or FDA investigator with answers as to why a change to an SOP was made, would you prefer to show them the current and previous versions with the changes apparent? Or would you rather hand over copies of reviewed and commented on SOPs. In my experience, having the history right on the document makes for very clear and concise reasoning regarding any changes made to the SOP. When faced with an auditor or investigator, you want to be certain that your retrieval of the recorded changes is fast and clean. It is also extremely beneficial and easy for anyone who would be taking over ownership/authorship of the SOP to see the changes. Like I said, it's just in my experience.


    -------------------------------------------
    Christina Starke
    Montvale NJ
    United States
    -------------------------------------------








  • 6.  RE:Change History of SOPs

    Posted 27-Jan-2012 11:44
    I would suggest that history of changes stay with the SOP and are listed as you suggested. knowing what changes were made to an SOP is useful for the user to understand why a document has been revised. Having this handy can be beneficial if a mistake was made or if the change had some kind of large impact say on a process. Knowing why a document was revised is important to training on that SOP and keeping it together rather that separate makes more sense to ensure compliance. I hope that helps with the question? ------------------------------------------- Darlene Rosario VP Research Program Management, Oncology MannKind Corporation Valencia CA United States -------------------------------------------


  • 7.  RE:Change History of SOPs

    Posted 27-Jan-2012 18:18

    We do both.  At the bottom of each SOP, we have a revision history with a cryptic message similar to your examples in point 1.

    We also keep a history (archived copy) of the old revision, and the redline version of the new revision.  The redline version is useful to see exactly what changed, and is often used in our training.

    -------------------------------------------
    Marshall McCarty
    Manager Regulatory Affairs
    Innovasis, Inc.
    Salt Lake City UT
    United States
    -------------------------------------------








  • 8.  RE:Change History of SOPs

    Posted 28-Jan-2012 14:42
    There are a number of methods that you can manage when it relates to maintaining the change history of your Standard Operating Procedures, Work Instructions, Quality Manual, and other documents like design control documents.  Both of the methods that you mention are acceptable and commonly used to show the change history of SOPs.

    The important point to remember is that whatever method you decide to implement, make sure this is reflected in your Document Control or Document Change procedure for how the change history is documented within your organization.  Organizations decide on the change history that is best suited for their company, which is either one or both of the methods you mention.  As pointed out in this discussion, it is helpful to have a summary of the changes for the revision to assist in training and highlighting the parts of the process that have changed.

    Change History in the Document:
    - Utilize the change history log as you mention by creating a list, table, or summary that has the changes provide in brief summary.
    - You can also have a Change History Table that is kept at the beginning or end of the document that provides a brief description of the changes being made.
    - We have also seen companies use methods in the actual document such as highlighting, asterisks, or bolding of the sections or parts of the document that were changed.
    - If you utilize a completely electronic versions for your documentation this becomes quite a bit easier as you can create linkage from your Change History table in the document to a Change Order request or use color-coding/highlights in the text of the document.

    Track Changes in the Document:
    - This is an excellent method to assist in training, see the changes, or provide objective evidence for the changes being made to the document.
    - A good method for track changes is to utilize a Change Order form listing the justification or rationale for the change, the approvals, the "red-lined" version document, and the "clean" version of the document.
    - Maintain the red-lined or track change version of the document in an archive location or obsolete location to show the changes that were being made to the document.
    - Again if you utilize an electronic document system this becomes easier as you can maintain the "track changes" version and a clean version in your electronic documentation system for easy review.

    There are a few methods that you can utilize including both of those you mentioned that are acceptable.  Just make sure that you describe in your document control procedure how these processes are managed.  Hope that helps and good luck.

    -------------------------------------------
    Richard Vincins RAC
    Vice President, QA
    Emergo Group Inc
    Austin TX
    United States
    -------------------------------------------




  • 9.  RE:Change History of SOPs

    Posted 29-Jan-2012 22:37
      |   view attached
    Hi! Wajeeh,

    The best option is always the simplest one as the compliance goes up for steps that are easy to follow. I suggest the first option where you simply list the major changes at the begining or end of the SOP. Track changes could be confusing for the user. From your address I am assuming you are mostly dealing with GCP issues and also probably you have a higher personnel turn-over rate than a typical GMP, GLP site. Many GCP sites do not maintain elaborate SOPs, and since the personnel change so rapidly, they have to train more often on SOPs. The red-line version could get confusing for new personnel. It could also distract a trainee as they need to understand and follow the current process no matter how the change came about. The only people worried about changes are the ongoing personnel whose periodic training will cover the changes.

    I would also refer you an article that appeared in Regulatory Focus in Oct 2011 (see attached) for some general rules for SOPs.

    Kind Regards,

    Mukesh

    -------------------------------------------
    Mukesh Kumar RAC, PHD
    Senior Director, Regulatory Affairs
    Amarex Clinical Research
    Montgomery Village MD
    United States
    -------------------------------------------






    Attachment(s)

    pdf
    RAPS_Focus_SOPs_Oct2011.pdf   317 KB 1 version