Module 9 2021

19/03/2021

FDA Guidance Aligns with ICH Q5E

• Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products – CBER/CDER, April 1996 – Aim is safe, pure, potent and effective demonstration • Guidance for Industry: Comparability Protocols for Human Drugs and Biologicals - Chemistry, Manufacturing, and Controls Information – CDER/CBER, Draft April 2016 – Provides framework for assessing a change within the company – Allows changes falling within pre-agreed protocol (acceptance limits/tests etc) to have a reduced reporting (e.g. CBE not PA supplement)

The Organisation for Professionals in Regulatory Affairs

23

Quality Assessments: Assess Everything, Ignore Nothing

The Organisation for Professionals in Regulatory Affairs

24

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