Module 3 Presentations

07/05/2024

Definition of Specifications: Practical example (1/2)

Specification Pre-filled syringe system

Regulatory specification

Technical specification

Supply specification

Packaging drawings

P.7.03 Packaging – Specification and Test Procedure

P.7.02 Description of Primary Packaging

P.7.04 Drawing of Packaging Materials

P.7.05 Packaging – Batch Analyses

P.7.01 Packaging Material

„Development“ Packaging and Supply standard

„Production“ Packaging and Supply standard

One document per packaging material (incl. Secondary packaging materials)

In some cases a assembly drawing

One document for the whole system (describes primary packaging componen ts only)

One document per packaging material (incl. Secondary packaging materials)

One document per packaging material (incl.

One document per (primary) packaging material

One document per (primary) packaging material

One document per (primary) packaging material

One document per (primary) packaging material

Secondary packaging

materials) and packaging site

The Organisation for Professionals in Regulatory Affairs

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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

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