Module 3 Presentations

07/05/2024

Definition of Specifications

Technical Specification

Regulatory Specification

Supply Specification

Packaging Specification Framework

Regulatory Specification • Normally only for packaging materials with contact to the product (primary packaging materials) • Contains mainly requirements for identity testing • Is part of the dossier • Compliance with the regulatory specification must be verified for each batch of the packaging material

The Organisation for Professionals in Regulatory Affairs

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Definition of Specifications

Technical Specification

Regulatory Specification

Supply Specification

Packaging Specification Framework

Regulatory Specification / Relevant eCTD sections Module 3 • 3.2.P.Drug Product • 3.2.P.7 Container Closure System • Description of container system und its components

• Drawings of container components • Specifications and testing methods • Batch data

The Organisation for Professionals in Regulatory Affairs

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