Sample interview questions: Can you discuss your experience with method validation for different types of active pharmaceutical ingredients (APIs)?
Sample answer:
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Developed and validated analytical methods for a variety of APIs using HPLC, GC, and spectrophotometry.
- Worked closely with formulation scientists and quality control personnel to understand the critical quality attributes of the APIs and to develop methods that were specific, sensitive, accurate, and precise.
- Conducted method validation studies in accordance with ICH guidelines, including linearity, accuracy, precision, specificity, limit of detection, and limit of quantification.
- Documented method validation results in detailed reports that were submitted to the regulatory authorities.
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Experience with a variety of sample matrices, including tablets, capsules, creams, ointments, and injectables.
- Developed and validated methods for the analysis of APIs in complex sample matrices, such as those containing excipients, impurities, and degradation products.
- Utilized a variety of sample preparation techniques, such as extraction, filtration, and derivatization, to ensure that the APIs were properly extracted and concentrated for analysis.
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Experience with different types of APIs, including small molecules, peptides, and proteins.
- Developed and validated methods for the analysis of APIs with a wide range of physicochemical properties, including solubility, polarity, and stability. Read full answer