Table of Contents
Process Analytical Technologies
Validation
Qualification / Validation of Pharmaceutical Processes
European Agency Guidance for Process Validation
European Agency Guidance for Process Validation
Representative Dosage Forms
Solids: Tablets & Capsules
Powder Blending Operation
Liquids - Solution
Suspensions
Emulsions
Lyophilized
Ointments / Creams
Method Validation
Method Validation
ICH Topic Q2B Validation of Analytical Procedures
Considerations Prior to Method Validation
Examples of Methods That Require Validation Documentation
Method Characteristics to Be Considered for Validation
Specificity
Specificity
Linearity
Range
Accuracy
Precision
Detection Limit
Quantitation Limit
Impurities (Quantitation)
Robustness
System Suitability Testing
Regulatory Approaches
Compendial Analytical Procedures
Compendial Analytical Procedures
Appropriate Automation Can….
Advantages…Process Validation
Consequences of Inadequate Automation
Calibration and Maintenance
Compliance Issues…automated equipment
Compliance Issues…automated equipment (continued)
Closed System Controls
Closed System Controls (continued)
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