Chemistry, Manufacturing and Controls Community

  • 1.  Blend Uniformity Testing

    Community Leadership
    Posted 12 days ago

    Hello AAPS Friends,

    I am posting this as a thread to facilitate discussion regarding modern industrial blend uniformity testing practices. From what I have been able to gather, current guidance has been established via the International Society for Pharmaceutical Engineering (ISPE) as of 2014, after the FDA announced withdrawal of its Powder Blends and Finished Dosage Units draft guidance. However, it also seems that there are industry partners who potentially still employ the Product Quality Research Institute blend uniformity recommendation document (2002) guidance. Overall, I am hoping this post can help serve as a catalyst for communication/collaboration on current practices employed for blend uniformity testing, most especially clarification on testing practices and acceptance criteria followed.



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    Bo Tokarski Ph.D.
    Sr. Analytical Chemist, R&D
    Hims & Hers
    New Albany OH
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Blend Uniformity Testing

    Posted 4 days ago

    Thanks for starting a thread on the BU topic.  It's just great to have the BU thoughts of ISPE hidden behind a membership requirement.

    I have done BU/CU on many OSD products and have a few opinions and would really like to collaborate with an industry partner to generate and publish product data to support an extremely simple method to potentially justify eliminating BU testing in certain cases.  BU is subject to so much sampling error that it is really an exercise in developing a sample method that allows you to meet whatever criteria you are comparing against.   Of course, if you have a real BU problem, you may not be successful.



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    Dwayne Campbell Ph.D.
    President
    DCC Pharma Consulting LLC
    Cary NC
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 3.  RE: Blend Uniformity Testing

    Posted 4 days ago

    Dear AAPS Group Members,

    Thank you for initiating this important discussion on BU testing. I appreciate the opportunity to engage with experts and stakeholders on this topic and learn from the collective experience within the community.

    I would greatly appreciate it if we could consider organizing a webinar or virtual discussion with subject matter experts and key stakeholders to further explore the challenges, best practices, and emerging approaches related to BU testing.

    Thank you again for starting this conversation, and I look forward to the continued discussion.

    Best regards,
    Nagarjuna Mamidipalli.


    Sent from my iPhone



    Original Message