Sample interview questions: What is your approach to ensuring the quality and reliability of analytical reference standards used in pharmaceutical analysis?
Sample answer:
Approach to Guaranteeing Quality and Reliability of Analytical Reference Standards
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Source from Reputable Suppliers: Collaborate with certified and ISO-accredited suppliers known for providing high-quality reference standards. Establish a rigorous vetting process to assess their compliance and track record.
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Certificate of Analysis (CoA) Verification: Thoroughly review the CoA accompanying each reference standard to ensure it contains all pertinent information, including purity, assay value, and batch number. Verify the information against reputable databases and independent third-party analysis.
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Independent Characterization: Conduct independent analytical characterizations of reference standards using multiple analytical techniques, such as HPLC, GC, and NMR, to confirm their identity, purity, and potency. This provides independent verification and reduces the risk of errors or misidentifications.
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Stability Monitoring and Storage: Establish a comprehensive stability monitoring program to assess the integrity and shelf-life of reference standards over time. Implement proper storage conditions to minimize degradation and ensure their reliability for extended periods.
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Traceability and Documentation: Maintain a robust system for documenting the prove… Read full answer
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