Announcements

Hello, Our monthly meeting is this Thursday,  3PM ET/12 PM PT.  We hope you can join us!

Agenda:

1. First time attendees/new member introductions 
2. Standing:  Items of interest from other Communities to AAPS

• Call for AAPS Volunteers for communities
• ICH Guidance Updates: ICH M4Q,  ICH Q1  - EFPIA/Bio/Pharma commenting through May -  Kayla/Lori/All

ICH Q1 – turn in comments to Bio on initial draft, mid-May

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

Link to the M4Q(R2) Work Plan - 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)

3. Member Engagement:  All

• PDA standard – LCM for analytical procedure  - Nanda
• Nanda shared PDF with Stability community. Kim provided link for commenting to those interested.
• Comments provided and uploaded week of 7/22  - Thanks Nanda and 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

4. Reminder:  2024 PharmSci 360

o   Stability Community Update at PharmSci 360 October

• 2 of Kim’s proposals accepted

o   Career Track:  How to Negotiate Contracts Like A Pro

• Technical Track: Data Control and Data Security Management in Pharmaceutical Quality Assurance
• Working on another topic for AI and career track

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

Use one Stability monthly meeting slot for webinar or virtual discussion. 

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

b.        Discussion Topic/Webinar in 3Q/4Q:  

• Shipping - USP chapter and recent articles  -  Survey responses and reflections –Camilla/Nanda
•  
• which studies are necessary vs good to have- Nanda interest in webinar/Kim suggest speaker 

§  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?  - align expectations between companies

• 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, Yogita)

• 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
• Focus on "Stability aspects of ADCs"  - could be a series 2-3 webinars if needed.   Timing:  5Nov ; part 2 in 1Q25
• Speaker planned: Prof. Schöneich from University of Kansas; Photostability of new modalities like ADC and gene therapy

7. Joint Quarterly Stability-Stats Community 

·        2Q (June 20):  Reference standard (RS) and use of long-term stability data to support requalification of RS  - Completed – Thanks Helen Strickland and Stephanie Ferrari!

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

·        3Q: Comparability Part II   - Dan W. for Stability; Stats - Aili Cheng  - Q3 meeting is Sep 12th

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

8. Open discussion