Module 3 Presentations

07/05/2024

Definition of Specifications

Technical Specification

Regulatory Specification

Supply Specification

Packaging Specification Framework

Regulatory Specification

• Definition based on initial samples

• Selection of suitable identity methods, if applicable by using compendial methods

• Aim: Clear confirmation of the identity of the materials

• The test methods in eCTD-chapter “Specifications and testing methods” shall ensure that the packaging material conforms to the description in section “Description of container system and its components”

• After selection of the method a testing needs to be performed in order to generate first figures (comparison values and limits)

• Specifications and tolerances should cover process related variability

• Important: Changes to the regulatory specification require an approval by the authority (e.g. after submission of a variation)

The Organisation for Professionals in Regulatory Affairs

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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

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

The Organisation for Professionals in Regulatory Affairs

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