Process Analytical Technologies

2/26/02


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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)

Author: LCS