Stability and Shipping Practices Opinion Poll This survey is intended to collect information from pharmaceutical companies regarding the design of stability studies used to support product shipments. Such studies are often called "transportation studies". The survey is expected to take 10 - 20 minutes to complete and is anonymous. The compiled answers will be reviewed at the AAPS Stability Community discussions. Thank you for your participation! Question Title * 1. What type of pharmaceutical products are evaluated for stability after exposure to shipping stresses? Please select all that apply Biologic - Cell Therapy Biologic - Gene Therapy Biologic - Vaccine Biologic - Recombinant protein therapy Biologic - Antibody therapy (example: monoclonal antibody) Biologic - Antibody-drug conjugate (ADC) Synthetic (small molecule) Other (please specify) Question Title * 2. What are the physical characteristics of the product? Capsules Frozen liquid Liquid Lyophilized Ointments/creams Tablets Other (please specify) Question Title * 3. What drug product presentations are evaluated? Autoinjectors Blister packs Bottles Kitted products On-body injectors Pre-filled syringes Vials Other (please specify) Question Title * 4. What is the long term storage temperature of the produc(s) selected above? 30°C 25°C 5°C -20°C -70°C Other (please specify) Question Title * 5. Is prior knowledge used for the shipping study design? Yes No If yes, please explain Question Title * 6. Is a risk analysis performed for each product? Yes No If yes, please explain how the risk assessment informs the study design Question Title * 7. What strategy is used to apply shipping stresses to stability samples? Real world shipping Simulated shipping Other (please explain) Question Title * 8. Please list any method or industry guidance that is followed for the transportation stresses applied to samples. Question Title * 9. How are the shipping stresses determined? Longest shipping route by a single mode (land, air, sea individually) Longest shipping route by a combination of modes (land, air, sea combined) Design of Experiments (DOE) based on the shipping factors Other (please specify) Question Title * 10. Select the factors that are included in the shipping study (select all that apply) Vibration stress Temperature stress (also known as temperature cycling) Light exposure Humidity exposure Seasonal considerations (summer/winter) Other (please specify) Question Title * 11. Are stresses from transport (vibration) and temperature (temperature cycling) applied to the same set of samples prior to evaluating on long term stability? Yes No Question Title * 12. Select the option that best represents the shipping studies performed at your company. Samples only subjected to shipping stress and then placed at the long term storage condition for evaluation. Samples only subjected to temperature stress and then placed at the long term storage condition for evaluation. Same set of samples subjected to both shipping stress and temperature stress and then placed at the long term storage condition for evaluation. Sample first evaluated at the long term storage condition for some length of time, then subjected to shipping stresses and placed back at the long term storage condition for evaluation. Reliance on shipping stress report(s) provided by packaging vendor. Other (please specify) Question Title * 13. What is the stability temperature used to evaluate samples after exposure to shipping stresses? Evaluate at the long term storage condition only (also known as the recommended storage condition, RSC) Evaluate at the long term storage condition plus the accelerated storage condition (ASC) and/or stress storage condition (SSC) Question Title * 14. What is the stability timeframe used to evaluate samples after exposure to shipping stresses? Specific intervals post-stress for standard timeframe (irrespective of product age) Resume the ICH test points and monitor through expiry for the specific lot Other (please specify) Question Title * 15. What is the testing strategy used to evaluate samples after exposure to shipping stresses? Full specification testing Minimized testing (select set of assays/methods only) Standard panel of tests applied to all products from which some tests are added or dropped depending on the product Other (please specify) Question Title * 16. How many lots of a single product are exposed to shipping stresses? One lot (1) Two lots (2) Three or more lots (3+) Other (please specify) Question Title * 17. What type of packaging is used in the shipping study? In-process packaging (boxes with dividers for vials, rondo trays for syringes, etc) Final packaged product Other (please specify) Question Title * 18. Are temperature tracking devices used in the shipping study, and if so, how are they used and how is the data evaluated? Yes No If yes, please explain Question Title * 19. Is the shipping study repeated for any of the reasons below? Reguatory filings in additional international regions (number of marketed countries increase) Additional packaging sites are added post-approval (after the initial market application submission) Additional manufacturing site added post-approval (same packaging site) New product presentation introduced post-approval (different syringe, vial, or device) Question Title * 20. Which functional takes responsibility for the design of the shipping study (stability test strategy)? Commercial Support Team Marketing Team Product Development Team Stability Team Supply Chain Team Other (please specify) Question Title * 21. Which functional area takes responsibility for the execution of the shipping stability study? Commercial Support Team Marketing Team Product Development Team Stability Team Supply Chain Team Other (please specify) Question Title * 22. Has your company received any rejections by regulatory agencies based upon the shipping study? Yes No If yes, please explain Question Title * 23. Has your company made post-market commitments related to shipping studies? Yes No If yes, please explain Question Title * 24. Has your company received any additional recommendations from agencies related to shipping studies? Yes No If yes, please explain Done