Module 3 Presentations

07/05/2024

Analytical Procedures

Why do we test pharmaceutical products? • PATIENT SAFETY IS PARAMOUNT

• Identity • Quality • Safety • Efficacy • Support of regulatory filings • Analytical methods must be appropriately validated

• Validation – documented evidence that an analytical method will perform as expected to assure identity, quality, safety and efficacy of the material being tested

The Organisation for Professionals in Regulatory Affairs

3

Analytical Method Lifecycle

Method development

Method validation

Knowledge Experience

Routine use

Method transfer

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