Module 3 Presentations

07/05/2024

Pharmacopoeial Methods and Validation

• Assumed to be validated • Official reference methods • Additional validation potentially required to demonstrate applicability to your product • Alternative methods allowable if equivalence (or superiority) shown • Better sensitivity, selectivity

The Organisation for Professionals in Regulatory Affairs

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The Future Analytical QbD?

• Science and risk based approach • Development of analytical methodologies in a systematic manner against pre-defined criteria • Gain deeper understanding of measurement systems • More robust and efficient process and product control strategies. • Improve reliability of the method by understanding, reducing and controlling sources of variability • Provide greater assurance that quality attributes of the drug substance, drug product or in-process materials can be reliably and reproducibly assessed. • Facilitates continuous improvement of methods throughout product lifecycle. • Provide opportunities for regulatory flexibility

The Organisation for Professionals in Regulatory Affairs

26

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