Spring Intro 2023

28/03/2023

3.2.P Drug Product 3.2.P.2 Pharmaceutical development

P.2.1 Components of drug product

Compatibility of drug substance with excipients rationale for choice of excipients

P.2.2 Drug Product formulation

Summary of development of drug product

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Overages, effect of physico-chemical properties

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P.2.3 Manufacturing process development

Development & optimisation of manufacturing process

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3.2.P.2 Pharmaceutical development Formulation and process development

ICH Q8 – Pharmaceutical Development: Implemented 2009 Introduced a regulatory requirement for a structured, rational approach to formulation development Key elements: • Identification of a Target Product Profile (what is the formulation intended to do?) • Identification of Critical Quality Attributes • Conduct of risk assessment to link input material and process attributes to Critical Quality Attributes (and thus identify the Critical Process Parameters)

• Develop a design space for the manufacturing process • Develop a control strategy to manage CPPs and CQAs • Monitor and refine through lifecycle

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