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  • 1.  Regarding Pest control

    Posted 20-Oct-2021 07:16
    Greetings of the Day!

    Can anybody clarifies regarding the requirements of pest control in a medical device industry? Does there is need of the approved pest control services and what are all certification are required to have with the pest control service provider.

    regards
    Shivani

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    Shivani Chawda
    Quality Assurance Executive
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  • 2.  RE: Regarding Pest control

    Posted 20-Oct-2021 08:03
    Hi Shivani,

    Since medical device manufacturer has to be ISO 9001  & ISO 13485 compliant, the Pest control requirements are part of these ISO guidelines.

    During the ISO audit, the auditor generally expects the manufacturer of medical device to have a annual contract with the Pest Control services in their factory and head office.

    You need to have Pest control contract with a vendor and other proof documents that the manufacturing facility is regularly treated by Pest control vendor.


    Hope this helps !


    ------------------------------
    Purvi Goradia
    Manager Regulatory Affairs
    India.
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    Original Message


  • 3.  RE: Regarding Pest control

    Posted 20-Oct-2021 08:12
    Dear Ma'am,

    Thank you so much for the message, I just wanted to know like is there any requirement that the pest control service provider that they should be ISO certified or any other regulatory certification?

    Regards
    Shivani

    ------------------------------
    Shivani Chawda
    Quality Assurance Executive
    ------------------------------

    Original Message


  • 4.  RE: Regarding Pest control

    Posted 21-Oct-2021 05:33
    Hello Shivani,

    Pest control is indeed a requirement inferred under Section 6.3 and 6.4 of ISO 13485 as well as many regulations.  In addition, pest control is a common GMP or current Good Manufacturing Practices as part of facility controls and maintenance.  This does also depend on the type of device as pest control can be a higher risk consideration for different devices such as sterile devices.  The expectation is pest control companies are on the Approved Supplier List (ASL) and qualified for the materials they use to conduct the pest control.  They do not need to be ISO certified.  However, the chemicals they are using for the actual pest control should be qualified and certified to local regulations.  There are also some pest control substances which should not be used or should only be used on the exterior of the facility.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Regarding Pest control

    Posted 21-Oct-2021 07:39
    Dear Richard,

    Thanks alot for clarifying my doubts.

    Regards
    Shivani



    Original Message


  • 6.  RE: Regarding Pest control

    Posted 21-Oct-2021 07:58
    We have a log where a general employee looks for evidence of pest ingress and then twice annually an external "Expert" that also does and signs off on an insection. Without the expertise an auditor will challenge competence to do the work.

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 7.  RE: Regarding Pest control

    Posted 21-Oct-2021 08:01

     

     

    LOL  Humorous typo there, Ed.  J

     

    "...signs off on an insection."

     

    Best regards,

     

    Ted

     

     

     




    Original Message


  • 8.  RE: Regarding Pest control

    Posted 21-Oct-2021 08:42
    LOL, my coffee isn't strong today I guess?

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 9.  RE: Regarding Pest control

    This message was posted by a user wishing to remain anonymous
    Posted 29-Oct-2021 17:29
    This message was posted by a user wishing to remain anonymous

    One other item to keep in mind re: pest control is you should consider your contract specifies notification for "change control" just as you would for other suppliers.  I am aware of a situation where the pest control supplier changed chemicals without notification, and this discrepancy between the chemicals used and the chemicals specified in the pest control work instructions for the site did not match, resulting in a finding.

    Which, of course, then leads down the rabbit hole of assessing the "noncompliant" pest control chemicals.
    Original Message


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