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  • 1.  SOP review timelines

    Posted 07-Apr-2018 08:48
    Multiple IVD medical device instrument companies I have worked at have had a 2 year review of SOPs.
    Does anyone know if this goes back to a guidance?


  • 2.  RE: SOP review timelines

    Posted 08-Apr-2018 10:26
    Hi Jeanne.

    Not sure if there is specific guidance on this but I do know that parts of the regulations speak to the idea that you are required to ensure that your product specifications adequately represent the product that you are selling.  I have always seen that if you can show the SOP to have been reviewed regularly it also improves any specific issues that might have arisen.  I believe our standard timeline is 2 years and I have seen it go up to 3 years.  But the idea is to always ensure that your system remains relevant and that you are continue to perform the SOP according to what is written there.  I have seen many companies (some of which I have worked for!) get caught up because some technology change or upgrade changed the way that they did the process in a particular way but that no one ever went back to ensure that they checked every SOP.  So at least having the regular review of SOP there is always the possibility that someone or something might change but the potential is mitigated at least to a certain level.

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: SOP review timelines

    Posted 09-Apr-2018 06:23
    Dear Jeanne,

    For biologics, there used to be a requirement in the regulations that written procedures had to be reviewed biannually. However, this requirement was removed.

    I advice manufacturers to review their SOPs on a sliding scale: more recent SOPs should be reviewed more frequently, for example annually, while SOPs that have been in effect longer are reviewed less frequently, perhaps every 2-3 years.

    Manufacturers have hundreds of SOPs. If you use this system, which is risk-based, it will be more likely that you will catch changes that need to be made in newer SOPs earlier while "tried and true" SOPs not likely to need change will be reviewed less frequently. This helps in the management of the review workload.

    However, as Victor says, if you know that a SOP needs to be revised based on a change in technology or process, it should not matter when the SOP was last reviewed - this SOP should be reviewed and changed ASAP.

    Sincerely yours, Suzanne
    --
    Suzanne M. Sensabaugh, MS, MBA
    President and Principal Consultant
    HartmannWillner LLC
    100 M Street SE
    Suite 600
    Washington, DC 20003
    Phone: 202-749-8616

    www.hw-fda.com

    LinkedIn address: http://www.linkedin.com/pub/suzanne-sensabaugh/5/4b0/335



    Original Message


  • 4.  RE: SOP review timelines

    Posted 09-Apr-2018 01:51
    I have seen it from annual (one year) up to 3 years ... well and companies not doing any type of review haha.  I think two years may be enough, but most management systems are shifting to a risk-based approach including if you are certified or following ISO 13485:2016.  This is another opportunity to use a risk-based approach on review period because some procedures may change often, i.e. complaint handling or risk management, while some procedures don't change very much, i.e. management review.  You should have a procedure review period, but take an opportunity to use a risk-based approach to identify those procedures in the QMS that have a greater impact that may need to be reviewed more often like annually, versus other procedures that have low impact or do not require that much change, to have a review period of 2 or 3 years.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


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