Module 3 2019

Definition of Specifications

Technical Specification

Regulatory Specification

Supply Specification

Packaging Specification Framework

Technical Specification

• Describes the product in detail, including

• Materials and product properties (e.g. Material data, Sterility, Endotoxin Level, Siliconization, EO residuals, Particulate Matter)

• Compliance requirements (e.g. Pharmacopoeia, Foodstuff regulations)

• Primary and secondary packaging of the packaging material

• Production requirements (e.g. Autoclavability)

• Logistical requirements (e.g. Shelf life)

• References to the Sampling plans, AQLs (Acceptable Quality Levels) and DEL (Defect Evaluation Lists)

•

Technical drawings

Includes requirements which could be tested during incoming goods inspection, but not all requirements should be tested!

The Organisation for Professionals in Regulatory Affairs