Module 3 2019

Definition of Specifications

Technical Specification

Regulatory Specification

Supply Specification

Packaging Specification Framework

Regulatory Specification

• Definition based on initial samples

• Selection of suitable identity methods, if applicable by using compendial methods

• Aim: Clear confirmation of the identity of the materials

• The test methods in eCTD-chapter “Specifications and testing methods” shall ensure that the packaging material conforms to the description in section “Description of container system and its components”

• After selection of the method a testing needs to be performed in order to generate first figures (comparison values and limits)

• Specifications and tolerances should cover process related variability

Important: Changes to the regulatory specification require an approval by the authority (e.g. after submission of a variation)

The Organisation for Professionals in Regulatory Affairs