Module 3 Presentations

07/05/2024

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

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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

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

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