Announcements

  • STABILITY COMMUNITY MONTHLY MEETING - THURS OCT 10, 12Pm PT/3PM ET

    Dear All,

    A reminder about our next meeting this Thursday, Oct 10th,  12 pm PT / 3PM ET.  Hope you can join us!

     

    Agenda:

    1. First time attendees/new member introductions 
    2. Standing:  Items of interest from other Communities to AAPS
      • ICH Guidance Updates: ICH M4Q,  ICH Q1  - EFPIA/Bio/Pharma commenting through May -  Kayla/Lori/All

    ICH Q1 - Lori – all comments turned in from different groups that are member of EWG – Bio, pharma etc  - public draft expected year end

    ICH went to EWG – group meeting together; not much info expected for a while; comments from constituent groups being review; public comment draft by end of year

     

    M4Q(R2) Work Plan Link - https://database.ich.org/sites/default/files/ICH_M4Q%28R2%29_EWG_WorkPlan_2024_0311.pdf

    Targeting Nov 2024 for Step 2 endorsement (public consultation)

     

                   CASSS CMC Strategy forum;   Ken share update at future meeting – Agenda

     

    3. Member Engagement:  All

    • Summary of this year’s Stability Community Activities – Vinaya & team
    • Encourage All to continue to engage over email and community page  (eg MFI for sub vis particulates, CCIT methods etc in previous months, Stability software query on the community)
      • Question regarding Appearance test result.
      • Appearance test is performed for parenteral product release and stability samples. When a test result 'product related particulates' is obtained, with acceptance criteria of '..... Essentially free of visible particulates.', do you consider the test result as a suspect OOS result that needs initiation of lab investigation?  

    4. Reminder:  2024 PharmSci 360

    o   Stability Community Update at PharmSci 360 October

                                                 Tue 22Oct – 5-6 PM – Room 151 ABCG – Stability Community meeting

    ·        2 of Kim’s proposals accepted

    Career Track:  How to Negotiate Contracts Like A Pro

    o   Technical Track: Data Control and Data Security Management in Pharmaceutical Quality Assurance

    o   Working on another topic for AI and career track  - full day focus;

    Artificial Intelligence Communication: the do's and don'ts for using AI language tools in your technical job at every level

    AI in scientific and technical writing - a conversation with David Hauss

    Generative AI in the Wild: Navigating your organization’s AI adventure!

    AI in quality and regulatory - the future is already here

     

    5. Increasing Member engagement: webinar and/or virtual discussion once per Quarter

    Virtual Panel Discussion (2Q):  at 9th May Stability meeting: In-Use Stability Topic  - completed

    Discussion Topic/Webinar in 3Q/4Q:  

    ·        Shipping - Survey responses and reflections –Camilla/Nanda

    o   Stability and Shipping Practices

    ·        Suggestions for future topics/presenters – All

    o   IQ consortium recent papers on In-Use stability; discussion of ICH Q14 ; Mini-case study from Jan WCBP, or similar to KENX San Diego 

    6. Sterile Products Community (if SPC members can join, Hitesh, Haresh)

      • Discussion on further collaboration : co-sponsor a presentation/ discussion with broader invitations
      • Last year, photostability;  culminated in a webinar that was broadly available with over 200 attendees
      • Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation
      • Timing:  19Nov – 12:30 -2  PM ET ; part 2 in 1Q25

    1Q2025 could have another related topic  - depends on SPC interest

     

    7. Joint Quarterly Stability-Stats Community 

    ·        4Q - Continue the RS topic/discussion in 4Q joint meeting? - Trending analysis ; expiry extensions – Stephanie F. to confirm with Helen

    • 3Q: Comparability Part II  - Sep 12th  Completed - Thanks! Dan W. for Stability; Stats - Aili Cheng 
    • 2Q (June 20):  Reference standard (RS) and use of long-term stability data to support requalification of RS  - Completed – Thanks Helen Strickland and Stephanie

    ·        1Q24: Use of means vs individual values to evaluate stability data  - Kayla Woodlief and Ben Ahlstrom – Completed - thanks!

     

    8. Open discussion

     

     

    Microsoft Teams meeting

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    Meeting ID: 282 196 477 610
    Passcode: 869yNv