I am currently benchmarking R&R's for Stability across the industry and would welcome your feedback in this exercise.
1. 1. How is Stability organized at your company?
a. GMP Clinical & Commercial are two separate functions
b. GMP Clinical & Commercial are in the same function
2. 2. Which areas are in scope for your Stability team? Select all that apply
a. Stability strategy
b. Expiry management
c. Sample Management
d. Reference Standards
e. Stability Design & Execution – GMP studies only
f. Stability Design & Execution – non-GMP and GMP studies
g. TOR/ToE
h. Patient Convenience
i. Patient Administration / In-Use Studies
j. Specifications
k. Other?
3. 3. What role does Formulation/Drug Product development play in Stability at your organization? Pick all that apply
a. Minimal
b. Conducts lead lot studies for FIH programs
c. Participates in the development of stability strategy
d. Own stability strategy & inform GMP team how to execute
e. Other?
4. 4. Which teams are responsible for the following studies?
Place an X in the appropriate column
|
Study / Item
|
Stability
|
Formulation Development/ Drug Product
|
|
Ambient Light
|
|
|
|
Photostability
|
|
|
|
Freeze-Thaw
|
|
|
|
Product Shipments
|
|
|
|
Labeling Allowance
|
|
|
|
Non-GMP (tox) stability studies
|
|
|
|
Patient Allowance/Convenience
|
|
|
|
In-Use /Administration studies
|
|
|
|
Temperature Cycling (clinical)
|
|
|
|
Temperature Cycling (commercial)
|
|
|
Thanks in advance for your feedback!
Kayla
------------------------------
Kayla Woodlief
Director
Vir Biotechnology
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------