Stability Testing is a process used in laboratories to check how well products maintain their quality over time and in different conditions. It's particularly important in pharmaceutical, food, and cosmetic industries. Think of it like a time-travel experiment where scientists check if products will stay safe and effective after sitting on a shelf for months or years. Testers put products through different temperatures, humidity levels, and light conditions to see how they hold up. This helps companies know how long their products will last (shelf life) and what the best storage conditions are.
Conducted Stability Testing for new skincare product line, ensuring 24-month shelf life validation
Led Stability Test programs for pharmaceutical products according to ICH guidelines
Managed multiple Stability Testing chambers and documented results for regulatory compliance
Developed Stability Study protocols for new drug formulations
Typical job title: "Stability Testing Scientists"
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Q: How would you design a stability testing program for a new product?
Expected Answer: A senior candidate should explain the process of creating testing schedules, determining appropriate storage conditions, selecting test parameters, and ensuring compliance with industry standards. They should mention risk assessment and resource planning.
Q: What would you do if stability test results show unexpected degradation?
Expected Answer: Should discuss investigation steps, including data review, root cause analysis, impact assessment, and developing corrective actions. Should mention documentation requirements and communication with stakeholders.
Q: What are the different storage conditions used in stability testing and why?
Expected Answer: Should explain common temperature and humidity conditions (room temperature, accelerated conditions, etc.) and their purpose in predicting product shelf life and storage requirements.
Q: How do you ensure the quality and accuracy of stability testing results?
Expected Answer: Should discuss calibration of equipment, proper documentation, use of controls, and following standard operating procedures. Should mention the importance of data integrity.
Q: What documentation is required for stability testing?
Expected Answer: Should mention basic documentation requirements like test protocols, data recording, sample tracking, and result reporting. Should understand the importance of accurate record-keeping.
Q: What safety precautions do you take when handling samples?
Expected Answer: Should discuss basic laboratory safety practices, proper handling of materials, use of protective equipment, and following safety protocols.