Module 3 2019

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