Below is an overview of the report's purpose and key contents to help you understand its role in pharmaceutical manufacturing. Core Purpose and Scope

shifts the spotlight to the physical packaging that keeps that drug safe until it reaches the patient

TR 27 warned that probabilistic methods often miss small leaks (5-10 µm) that can allow microbial ingress. This section is why regulators now prefer deterministic methods for final product testing.

The report emphasizes that integrity is not just a one-time test at the end of production. It must be considered throughout the product lifecycle: