Module 5 Presentations

18/07/2024

Product Specification File

– Protocols/randomisation codes – Technical agreements

– Manufacturing / Packing methods – Specifications & Analytical methods – Stability data – Approved label copy – Storage & shipment conditions – Clinical Trial Approvals – IMPD (Investigational Medicinal Product Dossier)

The Organisation for Professionals in Regulatory Affairs

9

Why are Clinical Trials different to Commercial marketed products?

 Added complexity  Lack of fixed routes – each repeat run may vary

 Lack of full process validation  Variety of clinical trial designs  Leading to variety of packaging designs  Leading to more complex packaging instructions  Use of randomisations and blinding  Increased risk of product cross contamination  Incomplete knowledge of potency and toxicity of the product  Increased risk of mix ups as products designed to look the same

The Organisation for Professionals in Regulatory Affairs

10

5