Module 3 2019

Definition of Specifications

Technical Specification

Regulatory Specification

Supply Specification

Packaging Specification Framework

Supply Specification

• Describes logistical requirements

• Ensures handling of the product within the goods receival area, sampling point and the warehouse

• Is based on negotiations between supplier/manufacturer and pharmaceutical company

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Examples: •

Pallet height

•

Tertiary packaging

• Requirements for labelling of pallets, tertiary packaging • Information about handling and labelling of supplier‘s random samples • Shipping addresses

The Organisation for Professionals in Regulatory Affairs