Module 9 2024

03/09/2024

What do the authorities focus upon during the technical review?

⚫ Compliance with regulations / requirements / Note for Guidance

⚫ Manufacturing consistency and process validation

⚫ Comparability of clinical lots versus commercial lots

⚫ Purity

⚫ Specification for lot release and justification

⚫ Starting / raw materials : origin, purity, testing

⚫ Stability and shelf-life

The Organisation for Professionals in Regulatory Affairs

European Union: Notice to Applicants, Vol. 2B

73

Non Clinical

Specific Considerations for Vaccines

The Organisation for Professionals in Regulatory Affairs

74

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