Sample interview questions: Can you discuss your experience with method development and validation for different types of impurities?
Sample answer:
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Method Development Experience:
- Developed analytical methods for various types of impurities, including residual solvents, heavy metals, pesticides, and process-related impurities, in pharmaceutical products and raw materials.
- Expertise in selecting appropriate analytical techniques based on the nature of the impurities and the regulatory requirements.
- Demonstrated proficiency in optimizing chromatographic conditions (HPLC, GC) to achieve efficient separation and detection of impurities.
- Developed and validated sample preparation methods to ensure compatibility with the analytical techniques and minimize matrix interference.
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Validation Experience:
- Conducted comprehensive method validation studies in accordance with ICH and FDA guidelines for various impurity methods.
- Evaluated method parameters such as linearity, accuracy, precision, specificity, sensitivity, limit of detection, and limit of quantification.
- Assessed the robustness of methods by introducing deliberate changes in experimental conditions to ensure the method’s reliability under varying conditions.
- Prepared detailed validation reports summarizing the validation results and conclusions, supporting regulatory submissions.
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Troubleshooting and Problem-Solving:
- Effectively resolved analytical challenges related to method development and va… Read full answer