Module 3 Presentations

07/05/2024

What are N-nitrosamines?

Examples

CHMP provided a Specific guidance in July 2020 relating to the call for review to MAHs • Applies to chemicals and biologicals • Procedural aspects and timelines. • Confirmatory testing requirements for products at risk. • Filing of variations.  The majority of products was identified not at risk of presence of nitrosamine  Confirmatory testing is pending for products identified at risk

https://www.ema.europa.eu/en/documents/presentation/presentation-update-activities-linked-presence-n-nitrosamines-human-medicines-azevado-r ruepp-ema_en.pdf Risk Assessment and Testing Requirements if product is at risk of presence of nitrosamine

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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Real Time Release (Parametric Release) • R eal T ime R elease T esting (RTRT): The ability to evaluate and ensure the quality of in-process and/or final product based on process data (e.g. IPCs) , which typically include valid combination of measured material attributes and process controls” 1 • RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control.  RTRT recognises that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end product testing and the context as such be an integral part of the control strategy. 2

1 ICH Q8(R2) 2 EMA Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

22