Module 3 2019

Definition of Specifications

Technical Specification

Regulatory Specification

Supply Specification

Packaging Specification Framework

Technical Specification

• Definition of the technical requirements

• Sources

• Pharmacopeias

• Guidelines, Regulations, Laws

• Material and product sheets

• Defect evaluation lists (Editio Cantor Verlag)

• Process requirements

• ….

The Organisation for Professionals in Regulatory Affairs