Controlling Organic Impurities in Pharma: ICH Q3A/Q3B and FDA Compliance Tactic

Low-level analysis can be very difficult. Basic issues in both qualitative and quantitative analyses will be described.

Why should you Attend: Trace-level analysis under Good Laboratory Practices or ISO 17025 is quite different when the target analytes are at very low amounts. The effect and requirements for accuracy, precision, selectivity, and other validation requirements are demanded are different than and more difficult to meet than those for higher concentrations. Basic parameters, such as precision and accuracy, are more difficult. Qualitative (identification of a molecule’s structure and identity) can be much more difficult.

Areas Covered in the Session:

• Official guidelines
• Uncertainty and identification
• Comparison to standard compounds
• Issues in accuracy
• Interferences and matrix effects

• Laboratory Personnel
• Quality Officers