Hello, Our monthly meeting is this Thursday, 12PM 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
- ICH Guidance Updates: ICH M4Q, ICHQ1 - Kaly/Lori/All
- KENX Lab University - Jun 4-6 (East Coast - Philadelphia): Lab management, Stability, Analytical Quality track
3. Member Engagement:
- Highlights & Reflections: Q1 Joint Quarterly Stability-Stats Meeting
- Significant interaction/discussion in the community regarding Stability/LIMS systems, shelf-life projections, etc - Kudos to the community!!
- Publications: Open access:
- Lean Stability Case Studies—Leveraging Science- and Risk-Based Approaches to Enable Meaningful Phase Specific Pharmaceutical
- 2 Articles: J. Phar. Innovation, Chris Latoz & Lori shared by email 3/19, 3/20 to Stats/Stability list
- Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes - AAPS journal 2024
4. Reminder: Topics for 2024 PharmSci 360 Submission
- Proposal Submission deadline Apr 8; Rapid Fire 14June; Call for proposals posted on Stability Community
- One topic identified at Jan meeting – Manvi Hasija;
- Others?
- Stability Community work with IQ Consortium to have a symposium at AAPS – Lori/Kim/Manvi
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
- In-Use Stability Topic identified - 5-6 discussion/focus points within topic (or benchmarking; Mini-case study)
- Summary 2 weeks (few focused topics) prior – post and publicize to AAPS community; cross-post on communities
§ Zoom meeting; post in Stability Community & CMC Community, AAPS LinkedIn
§ Dan, Sherilyn + Community member - Moderators/Expert
- Webinar in 3Q:
- suggestions for topics/presenters – All
- 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?
- e.g. discussion of ICH Q14 ; or Mini-case study from Jan WCBP
- similar to KENX San Diego -
- Stability aspects of ADCs – jointly with Sterile Product Community , 2-3 webinar series
- Shipping - USP chapter and recent articles - which studies are necessary vs good to have- Nanda interest in webinar setup/Kim suggest speaker
6. Sterile Products Community (if SPC members can join, Hitesh, Haresh, Yogita)
- 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.
7. Joint Quarterly Stability-Stats Community
- Reminder: Joint meeting with CMC Statistics Community: Lori/Kayla/Laura
- 2Q: Reference standard (RS) and use of long-term stability data to support requalification of RS - Helen Strickland from Stats; Stephanie Ferrari for Stability (Nanda is backup)
- 3Q: Comparability Part II - Dan W. for Stability; Stats - Aili Cheng
- 1Q24: Use of means vs individual values to evaluate stability data - Kayla Woodlief and Ben Ahlstrom – Completed - thanks!
Microsoft Teams meeting
Join on your computer, mobile app or room device Click here to join the meeting<https://teams.microsoft.com/l/meetup-join/19%3ameeting_NWUxZjY4ZGQtOGFlYy00ZmQ3LWFlZTctZDNjMzM3MzM4Yjdl%40thread.v2/0?context=%7b%22Tid%22%3a%221ad4c8f9-44ec-4870-9515-b42d64d49a4e%22%2c%22Oid%22%3a%220e166dbd-aa42-4622-9bb8-46a8a0178822%22%7d> Meeting ID: 282 196 477 610 Passcode: 869yNv