Module 3 2019

Definition of Specifications: Practical example (2/2)

Modular document system

• Documents will be re-used also for other packaging systems (e.g. only one “P.7.02 Description of Primary Packaging”, if the same stopper is used for different syringe formats) • “P.7.04 Drawing of packaging materials” → schematic drawing (H/W/L, without tolerances)

The Organisation for Professionals in Regulatory Affairs