Announcements

  • AAPS STABILITY COMMUNITY MEETING THIS THURSDAY 3PM ET/ 12PM WEST COAST TIME

    By: Vinaya Kapoor Vinaya Kapoor , 2 months ago
    Hello, Our monthly meeting is this Thursday.  We hope you can join us.

    Agenda:

    1. First time attendees/new member introductions

    2. Standing:  Items of interest from other Communities to AAPS

                   CASSS/WCBP Washington DC

                  Summary of Stability mini-case & workshop: mini-case study (Wed) + ICH Q1EWG + platform and prior knowledge 

     

    3. Member Engagement:

    - Highlights & Reflections: Photostability of Biologics webinar 7 Dec23 (Collaboration with Stability & SPC Community)

    - For reference: Stacey Royston <[email protected]> helped schedule webinar for AAPS; webinar recording link shared in January minutes  

    - Community member asked about AAPS publications


    4. Reminder: Topics for 2024 PharmSci 360 Submission -All


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

    Use one Stability monthly meeting slot for webinar and virtual discussion

    a) Virtual Discussion (2Q):  at 9th May Stability meeting

    §  Solicit topics/questions at Feb meeting  - e.g. benchmarking on certain topics; Mini-case study

        • 5-6 discussion/focus points within topic

    b) Webinar in 3Q: 

    • suggestions for topics/presenters – All
      • Shipping - USP chapter and recent articles - which studies are necessary vs good to have
        • controlling the operations- temperature of the trucks or the monitors instead of qualify every single shipping route?
        • perform risk analysis: shipping trucks break down and justify the study they perform.   
        • Any recent poll about shipping best practices? 

    6. KENX Lab University  - Jun 4-6 (East Coast - Philadelphia): Lab management, Stability, Analytical Quality track  

    7. Sterile Products Community (if SPC members can join)

      • Discussion on further collaboration : co-sponsor a presentation/ discussion with broader invitations
      • Hiten/Haresh proposed a similar webinar for this year. Focus on "stability aspects of ADCs" it could be a series 2-3 webinars if needed. 

    8. Joint Quarterly Stability-Stats Community

    - Reminder: March - Joint meeting with CMC Statistics Community: 

    • 1Q: Use of means vs individual values to evaluate stability data  
    • 2Q:  Reference standard (RS) and use of long-term stability data to support requalification of RS  
    • 3Q: Comparability Part II   

    Contact Vinaya Kapoor or Sherilyn Campie if you need the Teams link